6 MONTH PART-TIME DIPLOMA IN PHARMA REGULATORY AFFAIRS

AIPS is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.

Introduction to Regulatory Affairs

Good Manufacturing Practices, QA and Regulation

ICH

Dossier preparation and CTD Compilation

Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World

Clinical Investigational Studies

Pharma Patents, IPR and Regulation

Electronic Submissions

To register, please e-mail info@aips.ac.in

One day Seminar on PATENT STRATEGIES FOR PROTECTING INVENTIONS IN U.S., EUROPE & INDIA

Academy of Intellectual Property Studies, Intellectual Property Management - Mumbai, India organizes a one day seminar that will look at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and suggest strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars will also be studied, including freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, will add value to the event.

Dates January 18, 2011

For further information, send in youre-mails to info@aips.ac.in

Two day Seminar on the Indian Patent Act

Academy of Intellectual Property Studies, Intellectual Property Management - Mumbai, India organizes a two day training course providing an in-depth analysis of the Indian Patent Act. This course will be suitable for practicing professionals working in attorney firms or IPR Patent Cells, as well as those taking the Indian Patent Office patent agent examination to qualify as Registered Patent Agents. The methodology will be interactive, and the expert faculty will provide a Chapter / Section wise analysis of the Patent Act. Case studies and on-going Q&A sessions will give participants the opportunity to pose queries and become fully conversant with the nuances of the Act.

Dates: January 8 & 9, 2011
Faculty Dr. H. Subramaniam, Managing Partner, Subramaniam Natraj & Associates, New Delhi

DBT plans to broadbase SBIRI for benefit of more pharma, biotech units

The Department of Biotechnology (DBT) is planning to modify and expand the public private partnership programme 'Small Business Innovation Research Initiative (SBIRI)' based on the report of an ongoing expert review and suggestions from different stakeholders.

The DBT has invited applications from the companies for funding through loans and grants under the 15th batch of the SBIRI, even as it is keen to further modify the scheme to take the gains to wider sections of the industry, sources said.

The DBT has already entrusted the task of review with the IIM, Bangalore and is waiting for the report so that the programme can be modified accordingly. The Department has collected suggestions from different stakeholders to broadbase the scheme as per the industry preferences, it is learnt.

As per the latest records, the DBT has cleared 81 proposals so far for single industry projects and
collaborative ventures and extended soft loans and grants. The application for the current batch will close on February 28.

Sources said apart from expanding the base, the DBT is planning to monitor the projects initiated in the past in a better manner to ensure progress and development of products and processes. The SBIRI on-line system will be monitored for its effectiveness. Emphasis would be on innovation and validation and scaling-up of the proof-of-concepts obtained in various projects supported under this scheme. Some new ideas and concepts in different areas of biotechnology would be generated and new entrepreneurs will be encouraged further, sources said.
According to the announcement of 15th batch, proposals are being invited from pharma and biotech companies for 'for support of early stage, pre proof-of-concept research and development of research leads towards commercialization in all fields of biotechnology.'

The SBIRI assists small and medium business units including new enterprises with not more than 500 employees in R&D, offers phase I funding for early stage, pre proof-of-concept innovative research and provides Phase II funding towards commercialization of research leads.

Mumbai wholesalers may suspend purchase of drugs from AstraZeneca

The wholesalers from Mumbai may suspend the purchase of drugs manufactured by AstraZeneca soon, as they suspect the company is involved in selling physician samples of certain drugs directly to the patients. It was recently discovered that the company has been selling physician's samples of Onglyza 5 mg directly to the consumers in Andheri. Selling of medicines by companies directly to the consumer is illegal and punishable under Indian drug rules.

A source from the Pharmaceutical Wholesalers Association (PWA) informed that the company
representatives have been caught red handed selling physicians' samples of Onglyza 5 mg to the patients in Andheri. Onglyza is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. Physicians samples are not supposed to be sold to patients without prescription. The Association is contemplating to file a complaint with the competent authority against the company and others involved in this case.

It is suspected that apart from the company, even a chemist and some doctors from this area are involved in such unethical practice. In this case, its the patients who are suffering the most. They are being fooled by the chemists who are giving them PS without a proper bill, the source said.

The only way in which a medicine can be bought is through a valid prescription from a doctor without which it is deemed to be illegally obtained. It is understood that under the rule once a drug gets an approval the company is supposed to send the medicines to the clearing and forwarding (CNF) agents then it comes to the stockist and from there they are supplied to the chemist and finally to patients.

The main aim behind providing sample to physicians is to obtain a qualitative analysis of the performance of drug from the doctor after the completion of survey as its an important part of the clinical trial stage IV. Whereas the other important objective is to create awareness about the brand name among the doctors.

Guidance for submission of Biological Application (Vaccine)

CDSCO has issued new guidance and checklist for submission of Biological application (vaccine) in order to accelerate the review process. This checklist will be utilized for review w.e.f January 1, 2011

Checklist:
1. Permission for Conducting Clinical Trial (Phase I, II and III)
2. Global Clinical Trial
3. Market authorization / New Drug approval
4. Import License (Form 10)
5. Registration Certificate (Form 41)
6. Post approval Changes.
7. Test License for import of drugs under Form 11.
8. NOC for manufacturing of test batches for test and analysis under Form 29.

Click here for more information on the guidelines

Christopher Viehbacher Becomes New PhRMA Board Chairman

Christopher Viehbacher, chief executive officer of sanofi-aventis, became chairman of the Board of Directors of the Pharmaceutical Research and Manufacturers of America upon the resignation of Jeffrey B. Kindler of Pfizer.

In assuming the chairmanship of PhRMA, Viehbacher outlined priorities for the industry.
“As an industry, we will continue putting patients first by delivering innovative, difference making medicines that address unmet medical needs,” said Viehbacher. “Given the increased prevalence and costs of chronic disease, our industry needs to work with other healthcare stakeholders to encourage the prevention and better management of chronic disease.”

“Chronic disease gives rise to 75 percent of our national health care spend. I look forward to working with my PhRMA colleagues and with others across the health system to advance policies that recognize the strategic importance of our industry in terms of better health for patients, economic growth and jobs,” said Viehbacher.

“Under Chris Viehbacher’s leadership, we will continue to work for sound policies that bring the benefits of medical innovation to patients, reward investment in R&D, help create jobs and promote economic growth in the U.S.,” said PhRMA President and CEO John J. Castellani. “Chris has been a vocal champion for better prevention and treatment of chronic disease – the true driver of rising health care costs. We look forward to working with him on this and many other challenges in the year ahead.”

“We also thank Jeff Kindler for his steady guidance and vision during a challenging period for our sector. Jeff helped navigate us through the passage and implementation of health care reform, in the process strengthening Medicare Part D and expanding coverage to millions of Americans in need. We wish him the very best going forward.”

Ayush hospitals in Tamil Nadu running out of medicines for the last six months

The Ayurveda, Siddha and Unani hospitals in Tamil Nadu are running out of all kinds of medicines for the last six months, forcing the patients to change their system of treatment. Some of the hospitals are dispensing very few medicines just to manage the functioning of the hospitals.Major supply of medicines to these hospitals is done by the government owned company, Tamil Nadu Medicinal Plant Farms and Herbal Medicine Corporation Limited, (Tampcol), but for the last six months its supply has become weak because of several reasons.

Adding fuel to fire, the employees in Tampcol had resorted to strike last month, which was withdrawn later by the interference of the health secretary. Whereas, additional supplies are done by one private company on contractual service, which is also not delivering the medicines on time, the doctors of district and taluk hospitals told Pharmabiz.“Improper and irregular supply of medicines by Tampcol is the main cause of the worsening situation of the government Siddha hospitals here. It cannot supply to all centres. All the hospitals and PHCs are experiencing the same situation. Some particular medicines are not being supplied for the last three months despite repeated intents. Previously there was one private company for contract supply and they used to deliver properly. Now the government has given contract to a new company which is unable to supply the medicines”, remarked some doctors.

A district medical officer from southern districts said large number of patients are coming with chronic ailments such as arthritis, skin diseases, psoriasis, eczema, leucoderma, etc. In addition to these, people suffering from viral fever are also coming for medication. The most moving and common medicine, Pinta Thailam, is not available in any of the hospitals in the state. It was supplied by Tampcol and used for Arthritis and body pain. But occasional supply is done to hospitals under NRHM, attached to allopathic PHCs, but that too is very limited.When contacted, a senior officer at the ISM directorate said that two private companies, Nethaji Pharma, Dindukkal and Lekshmi Seva Sangham, Dindukkal, have been given assignment to supply medicines in addition to Tampcol and soon their delivery will be commenced.

The officer added that the delay was mainly due to some internal issues of Tampcol which has been solved recently. But when contacted, an officer in the marketing department of Tampcol said that there is no shortage of medicines in the hospitals. He refuted that there is neither discontinuation of supply, nor strike in the company and said that everything is going on smoothly. But he said if there is any problem, it will be sorted out soon.

According to sources, the government supplier, Tampcol is able to supply only 50 kinds of medicines. A minimum of 90 to 100 types of medicines are needed in a Taluk Hospital to prescribe medications for various diseases. Dr T Thirunarayanan, a Siddha medical researcher and Ayush scholar in the state said the ISM Hospital Pharmacopoeia mentions about 400 medicines and the Essential Drug List of Ayush describes 180 medicines. He said it is high time for the government to interfere in the matter as the state has big tradition for Siddha method of treatment.Besides this deteriorating condition, several hospitals and teaching institutions are reeling under severe shortage of medical officers and lecturers. This unfortunate state of affairs in the hospital-cum-colleges is adversely affecting the functioning of these institutions.

Indian Pharmaceutical Congress (IPC) 2011

Indian Pharmaceutical Congress (IPC) 2011 will be hosted at Karnataka. There is also discussions on creating KIPER(s) (Karnataka Institute of Pharmaceutical Education and Research).

Patients recommended to continue the use of recombinant human growth hormone

FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider.

This recommendation has come based on the results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study which found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

Upcoming FDA Advisory Committee Meetings

Upcoming FDA Advisory Committee Meetings:

Gastrointestinal Drugs Advisory Committee
DATE: January 12, 2011 TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993 CONTACTS: Kristine T. Khuc, Pharm.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, WO31-2417, Silver Spring, MD 20993-0002, 301-796-9001.

The committee will discuss the safety and efficacy of new drug application (NDA) 022486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas.

Peripheral and Central Nervous System Drugs Advisory Committee
DATE: January 20-21, 2011
TIME: Day 1, 8:00 a.m. to 5:00 p.m.
Day 2, 8:00 a.m. to 12:00 noon

LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993 CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research , Food and Drug Administration, WO31-2417, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, 301-796-9001.

On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease.
On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain.

Neurological Devices Panel of the Medical Devices Advisory Committee
DATE: January 27-28, 2011
TIME: Day 1, 8:00 a.m. to 6:00 p.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD.

CONTACT: James Engles, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area)

The committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

Oncologic Drugs Advisory Committee
DATE: February 9, 2011
TIME: 8:00 a.m. to 12:30 p.m.
LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993

CONTACT: Nicole Vesely, Pharm.D., Food and Drug Administration, 10903 New Hampshire Avenue WO31-2417, Silver Spring, Maryland 20993-0002, Phone: 301-796-9001, E-mail: Nicole.Vesely@fda.hhs.gov

The committee will discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers Squibb Co.. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

Doctors and pharmacists in Hungary to be encouraged to prescribe cheaper drugs

The government is planning to change the law by introducing premiums to motivate doctors and pharmacists to prescribe cheaper drugs in Hungary.According to the National Health Insurance Fund (OEP), savings of about HUF 3-4bn (€10.8-14.4m) could be shared among doctors as premiums every year.Doctors in Hungary are, to some extent, obliged to offer patients the cheapest medicines, as doctors’ habits in the arena of drug prescription are monitored by the National Health Insurance Fund (OEP) in four therapeutic areas: gastric diseases, diabetes, high blood pressure and the reduction of blood fat levels. If the prices of drugs prescribed by a particular doctor are at least 50% higher than the average, he or she is obliged to participate in a special course.Pharmacists, despite the fact that they are obliged to offer the patient a cheaper drug equivalent, in accordance with Act XCVIII of 2006, are not yet interested in offering them, because lower margins would mean less income for pharmacies.

Two-Day Workshop on Practical GCP for Successful BA/BE Studies

Two-Day Workshop on Practical GCP for Successful BA/BE Studies

Dates: 7-8 January 2011
Location: Hotel Four Points by Sheraton, Vashi, Navi Mumbai

By
Arkus Clinical Trial Support Solutions, Ahmedabad &
PharMantra Consulting Services, Hyderabad

Trainers :- Dr. Anupama Ramkumar, M.D.
Ranjani Nellore, Ph.D., RAC

Cost of the program: Rs. 9250/-
(Inclusive of course material, lunch and refreshments)

Who would benefit?
All clinical research professionals in BA/BE studies in sponsor and CRO companies, principal investigators, monitors & auditors responsible for GCP compliance. This workshop will provide invaluable insight into practical aspects of BA/BE studies, with respect to GCP applications and systems to ensure execution of regulatory compliant studies and exceed customer expectations.

About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP trainer & consultant in India and runs Arkus Clinical Trial Support Solutions, a rapidly growing, training and consulting firm engaged in assisting sponsor companies running their trials in India, auditing and monitoring CROs/sites and other vendors for optimal trial conduct and logistics. She has been a part of the clinical research Industry in India since its early days and has herself been an Investigator on Phase 1 trials while working as the Medical Director at Lambda Therapeutic Research, Ahmedabad,India.

Ranjani Nellore, Ph.D. RAC is a regulatory affairs certified professional with over 12 years of pharmaceutical industry experience in USA and India. She has submitted clinical trial applications and INDs to FDA, MHRA, TPD (Canada) and DCGI for several NCEs. She has participated in meetings with the EMEA and USFDA. She is an invited speaker at national and international meetings and renders customized training programs. She has now established PharMantra Consulting Services which provides regulatory consulting services to the global health science industry.

If bioequivalence is part of your business, Don’t miss this workshop!!
To register, please send email to:Anupama@arkusresearch.com ; ranjani@pharmantra.com or

Call Dr. Anupama at 98254 13761 or Dr. Ranjani at 99590 72225

62nd Indian Pharmaceutical Congress (IPC) Manipal, 2010

Manipal University has not hosted anything as big as the 62nd edition of the Indian Pharmaceutical Congress (IPC) beginning here today. Close to 10,000 delegates from all over the country and some from abroad are expected to participate in the three-day event. Over 2,000 of them have already arrived in the education township. Manipal College of Pharmaceutical Sciences, hosts for the event this year, is all set for the big event.

Chief Coordinator and Principal of MCOPS, Dr N Udupa said that the preparations were almost over and, “We are just waiting for the event to get underway today at 5.30 pm at KMC Greens”. Dr V S Acharya, higher education minister of the state will inaugurate the Congress. Some of the other dignitaries who will be present as guests of honour for the inaugural function are; Dr B Suresh, vice chancellor, JSS University, Mysore who is also the president Pharmacy Council of India and entrepreneur Dr B R Shetty of Neopharma, Abu Dhabi.

Some of the delegates are alumni of MCOPS. They met this morning at Fortune Inn Valley View and set the tone for the mega event. Dr BR Shetty, also an alumnus, was the chief guest at the function. The three-day meet began with a felicitation function at FIVV at 9 am and was followed by the inauguration of the pharma exhibition by FICCI which was inaugurate by Dr Shetty.The inaugural and closing functions are being held at KMC Greens and so will the entertainment programmes in the evenings. The rest of the activity will be held mainly on the MIT campus.The scientific sessions will be held in the lecture rooms. The posters will all be put up in the new food court, which has a massive space, and, about 4,000 delegates will be staying in the MIT hostels. Food for all the delegates will be served at the MIT football and hockey ground which has been enclosed for the purpose.The exhibition which will be one of the main attractions of the Congress will be held at the MIT stadium. The entire stadium has been turned into a huge exhibition centre with top end machines on display in the stalls. More than 150 exhibitors will display their wares.Coming to the Sessions itself, top priority has been given to enhance the science content of the Congress and discuss the recent advancements in pharmaceutical sciences and profession.

There will be 85 lectures in all to be delivered by 55 Indian and 30 foreign speakers. Sixteen symposia have been planned with stress on specific areas of interest, one of which will be on the Menace of Spurious Drugs. This is a subject of intense worldwide interest as it threatens the health of drug consumers.Entertainment programmes will be at KMC Greens. On December 18, 2010 Swaratma Fusion Rock Band (Mumbai) will provide high-octane music, it will be the turn of the local talents of Manipal University to perform the next day. On both days, entertainment programmes will be held at Syndicate Bank Golden Jubilee Hall, performed by Thakur and Co.

IPC Pharma Expo 2010 kicks off at Manipal with plant machinery, lab equipment displays

The 'Pharmaceutical Expo-2010' organised by the Federation of Indian Chamber of Commerce & Industries (FICCI) in association with the 62nd Indian Pharmaceutical Congress (IPC) was inaugurated by Dr BR Shetty, managing director, Neopharma, Abu Dhabi. Leading pharma plant machinery and lab equipment manufacturers like Shimadzu, Waters and Millipore have made their presence by displaying their latest equipments at the Pharmaceutical Expo..The exhibition with 150 stalls, spanned over an area of 6,000square metres, is expected to have 8,000 visitors. The mega event has visitors trickling in. However, the participants are of the view that it would be more of students. Going by the increasing number of pharmacy colleges and fewer job openings, pharmacy students are looking to be present in such events to chalk their future job prospects, according to a section of the industry.

There are also companies from the contract research and manufacturing services (CRAMS). These include Biocon's subsidiary Syngene and Anglo French among others. Ronald Mascarenhas, head, human resources, Syngene International said, “ the main intention for our participation is to help create a pool of fresh Pharmacy graduates and post graduates. Going by the challenge of accessing the right personnel, expos such as IPC which lure a large student population is a platform for planning our campus recruitment”, he added.

According to FICCI's Kamal Bharadwaj, assistant director, Trade Fairs, FICCI, the expo is expected to see a huge interest going by the displays of plant machinery and lab equipment. He said,”Going by the educational environment of the town Manipal which boasts of its centres of learning, we have received a good response and we hope to have around 5,000 business and general visitors. The Expo which was a hub for foreign participation has so far seen only representation from Korea and US”.There are a couple of interesting exhibits for liquid dispensing. In the lab equipment front, Millipore is exhibiting the MilliQ, Snap IDand Sceptor. The novel Sceptor is a hand held cell counter is a product of the future. Waters' display includes Zevo TQS, besides balances and cartridges.

The pharmaceutical industry in India has been growing at the rate of 12-13 per cent and has garnered revenues to the tune of Rs. 68,000 crore. To sustain this growths in the face of competition both domestic and international, it is required for the industry to keep update technology, source raw material at competitive rates and improve over all productivity. To this end, they do need to visit the exhibition and source their requirements appropriately, stated Bharadwaj.Some of the big participating companies are Shimadzu, Millipore, CVC Technologies,Associated Capsules Group, Cadmach, Bectochem, Precision Gears, Pharmalab, Fabtech, Ambica Machine tools, Flow Control Industries.

Expert inspection panel on clinical trial on Bhopal gas tragedy victims finds deficiencies

The expert committee which went into the allegations of engaging the victims of Bhopal gas tragedy for clinical trials has cited some ‘deficiencies’ in the procedures and the Health Ministry has asked for clarifications from the principal investigator Dr Pradeep Bhattacharya and the Bangalore-based firm involved in the matter, Quintiles Ltd.

The inspection of Bhopal Memorial Hospital and Research Centre was carried out in the month of October by a team of experts set up by the Central Drugs Standard Control Organisation (CDSCO) for a clinical trial titled “A phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Pneumonia with a Focus on Patients with Infections Due to Methicillin Resistant Staphylococcus aureus’’ (Protocol No. 0015).

“Findings of the inspection showed some deficiencies for which principal investigator Dr Pradeep Bhattacharya and Quintiles Ltd., Bangalore (CRO) were asked to explain their position. Quintiles., Bangalore has already submitted its reply,’’ sources said, without giving further details into the deficiencies reported by the panel and the reply given by the investigator or the CRO.The reports claimed that the patients suffering from various ailments following exposure to Methyl-Iso-Cyanate in the Bhopal tragedy in 1984 were being used as guinea pigs at the BMHRC to test different unapproved medicines by multinational drug firms, and the issue has created furore across the country.

The research centre, set up in 2000, was also reportedly carrying out studies on long term effects of Methyl-Iso-Cyanate (MIC) poisoning, thus raking up suspicions about clinical trials by multinational companies. It was also alleged that the required code of ethics for conducting trials was being violated. The drugs allegedly used in the trials included telavancin (patented by US company Theravance), tigecycline (Wyeth), prasugrel, fondaparinux (GlaxoSmithKline) and fixed-dose combination of cefoperazone with sulbactum (Magnex) sold by Pfizer in India.However, it is not clear whether the inspection panel has listed out the names and drugs of the companies cited in the media reports.

The CDSCO authorities still maintained that they did not get any complaints, but the inspection was ordered following the media reports.

DCGI to introduce 'Preliminary Scrutiny' for approval of FDCs from Jan 1

Aiming to streamline the submission of application for approval of Fixed Dose Combination (FDC) drugs and their review by the drug authorities, the Drug Controller General of India (DCGI) has introduced a system of 'preliminary scrutiny' of such applications while receiving them to determine the acceptability for review by the DCGI office.

This will come into effect from January 1, 2011.The new system is intended to avoid unnecessary delays in approvals of FDC applications. So far, the applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses which could result in unnecessary delays in approvals.

The preliminary scrutiny of the applications will be done by CDSCO officers based on checklists prepared for each of the several categories of FDC. During the preliminary examination, the CDSCO officers will scrutinize the applications to ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist. If application submitted is not in accordance with the format and the checklist, it will not be accepted by CDSCO.Once an application is accepted, the adequacy of the data will be reviewed by CDSCO as per the specified requirements and guidelines. In case the data submitted is not adequate or satisfactory, applicant will be requested to generate/submit adequate data for consideration and approval of the FDC.The proposed fixed dose combination should be based on therapeutic rationale.

The applicant is required to justify the combination based on the rationale. While submitting the rationale for a FDC, the applicant must address the issues like drug-drug interaction between the ingredients, food effects and dosage schedule of individual active ingredients vis-a-vis that of the FDC. Further, the indication/claim for the FDC should be such that the individual active ingredients makes a contribution to the claimed effect and the product should be formulated so that the dose and proportion of each substance in the FDC is appropriate.Trial batches of new drugs for test and analysis/clinical trial/BE study purpose should be manufactured after obtaining Licence in Form 29 from the concerned State Licensing Authority and copy of the licence should be submitted along with the application. While submitting reply to a query, the applicant should always enclose with the reply, a copy of query letter issued by CDSCO.The applicant should submit stability data generated on 3 trial batches manufactured by them under Licence in Form 29 issued by State Licensing Authority (SLA). The stability data and the clinical trial protocol should be submitted as per the CDSCO format.

In case of clinical trial/ bioequivalence study NOC, the applicant should submit the adequate chemical and pharmaceutical information. The applicant should always submit certificate of analysis, dissolution data (in case of oral dosages form, as appropriate), stability study data etc. in respect of formulation, duly signed by the In-charge/Manager QC.Before preparing the application, the applicant must categorise their proposal and submit information as per the checklist for that category. Application in Form 44 should be complete in all respects and signed by the authorized person of the firm with name and designation. The TR challan receipt submitted by the applicant should mention the name of the FDC including correct head of the account, payable at, bank clearance, etc. The documents must be submitted with indexing and page number. Without indexing or page number, no application will be accepted. Clear and unequivocal information should be provided along with the application.

Avastin may no longer be used for the treatment of breast cancer

The U.S. Food and Drug Administration has recommended to removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

This recommendation has come after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

The drug is also approved for the treatment of colon, kidney, brain, and lung cancers. The recommendation that came today does not affect the use of Avastin for other indications.

Genentech, the manufacturer of Avastin has not agreed to remove the breast cancer indication voluntarily, so the FDA has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination.

Additional studies of Avastin in patients with metastatic breast cancer could be conducted by Genentech to identify a population of patients in which the drug’s benefits exceed the risks

21 M Pharm students selected for this year’s ‘TNPSWT’ M Pharm Scholarship Awards

The Tamil Nadu Pharmaceutical Sciences Welfare Trust (TNPSWT) has selected 21 final year M Pharm students from various pharmacy colleges in Tamil Nadu for this year’s M Pharm Scholarship Awards. The awards were instituted by TNPSWT and are being given to selected M Pharm students for their on-going project work.

268 applications were received from seven different branches of pharmacy from 19 colleges. 262 synopses were sent to Dr Madhusudan Rao, Principal, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, and his team for evaluation. Based on their best marks, students have been selected for award of scholarship.

Each branch of pharmaceutical sciences is given three scholarships with first, second and third ranks and there are seven branches. The first rank carries Rs. 8000, second rank, Rs. 7000 and Rs. 6000 for the third rank. Pharmaceutics, pharmaceutical chemistry, pharmaceutical analysis, pharmacology, pharmacognosy, pharmacy practice and biotechnology are the branches in which scholarships were awarded.

K R Vimal of PSG College of Pharmacy, Coimbatore has won the first rank of scholarship for the branch, pharmaceutics. Syam Potnuru of Adhiparasakthi College of Pharmacy, Melmaruvathur, won the second rank. The third rank holder is Anindita De of JSS College of Pharmacy, Ooty.

In pharmaceutical chemistry, the winner is S Jeevanantham from RVS College of Pharmacy, Coimbatore, the second rank goes to V Hemalatha of SRM College of Pharmacy, Kattankolathur and Sona Joseph from KMCH College of Pharmacy, Coimbatore bagged the third rank.

E Kumanan from Adhiparasakthi College of Pharmacy, Melmaruvathur is the first rank holder for pharmaceutical analysis and K Harsha Manjusha from JSS College of Pharmacy, Ooty ranked second. M Manu from RVS College of Pharmacy, Coimbatore bagged the third rank.

In pharmacology, the first rank goes to Kalpana Eluri of PSG College of Pharmacy, Coimbatore and R Ranjith Kumar from the same college has been selected for the second rank. R Anand from KM College of Pharmacy, Madurai is the third winner.

In pharmacognosy the first rank for scholarship was given to M Mubeen of Madurai Medical College, Madurai and V Jothi Rani of Arulmigu Kalasalingam College, Srivilliputhur has been chosen for the second. Aparna Sarepaka of JSS College is the third winner.

In the branch of pharmacy practice, the first rank was given to Raj Kucherlapati VSP of JSS College of Pharmacy, Ootty, and Merin Levy Philips from SRIPMS, Coimbatore got the second award. C Karthic Kumar from JSS College of Pharmacy, Ooty bagged the third rank.

In biotechnology, the first rank was given to N Karthikeyan of SRIPMS, Coimbatore and S Karthikeyan of the same college bagged the second rank. The third rank went to Mahesh Thondawada of JSS College of Pharmacy, Ooty.

China and India set to become World leaders for innovation

China is set to become the world’s powerhouse of innovation over the next decade, eclipsing the United States and Japan, according to an international survey released by AstraZeneca today.
The world’s most populous nation and second largest economy will also be its most inventive by 2020, followed by India.

The survey of 6,000 respondents across six countries portrays a strong sense of optimism amongst people living in the developing nations of China and India about the ability of their nations to prosper through innovation – in stark contrast to the views of those in developed Western economies.

when asked which country will be the most innovative a decade from now, China, which is also forecast to overtake the US as the world’s biggest economy by 2020, comes top with 27 per cent, followed by India on 17 per cent and the US with 14 per cent. Japan is in fourth place with 12 per cent, while just two per cent of respondents think Britain will rank as the world’s most innovative nation in a decade’s time.

From the survey:Indian citizens consider the US to be the most innovative country in the world (29 per cent) but 16 per cent think their own country can already make that claim and 56 per cent believe it will be the case by 2020. Three in ten Indians think India provides the most supportive environment for innovation while IT & telecoms (66 per cent) and media (45 per cent) are viewed as the most innovative industries. The computer is voted the greatest innovation of the last 100 years and instant global communication (42 per cent) is seen as the greatest achievement of the last century, compared with 16 per cent who nominate the eradication of serious diseases

Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) accredited organizations

More than 800 organizations, institutions and companies in 34 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use and good science.

Accredited Organizations as of December 8, 2010
3M Company
60th Medical Group (AMC)//MDSS/SGSEV, Clinical Investigation Facility
Abbott Laboratories, Abbott Bioresearch Center, Inc.
Abbott Laboratories, Abbott GmbH & Co. KG
Abbott Laboratories
ABC Laboratories, Inc., Analytical Bio-Chemistry (ABC) Laboratories, Inc.
Absorption Systems, Inc.
Advinus Therapeutics Pvt. Ltd.
AFRL/HEDV, Air Force Research Laboratory
Agdia, Inc.
Akron General Medical Center, The Kenneth Calhoun Research Laboratory
Albert Einstein Healthcare Network, Albert Einstein Medical Center
Alcon Research, Ltd., Alcon Research, Ltd.-Fort Worth, Texas
Alion Science and Technology Corporation, Alion Science and Technology Corporation to Alion Life and Environmental Science Operation
Allergan, Inc.
Alnylam Pharmaceuticals
Alpha Genesis, Inc.
Ambrx, Inc.
American Foundation for Biological Research, Biomedical Research Institute
American Preclinical Services, LLC
American Type Culture Collection
Ames Research Center-National Aeronautics and Space Administration, Animal Care Facility
Amgen Inc., AWA R&D
Amgen, Inc., Amgen Massachusetts
Amgen, Inc., ASF R&D
Amgen, Inc., ATO R&D
Amylin Pharmaceuticals, Inc.
Aptuit (Edinburgh) Ltd.
Aptuit, Inc., Aptuit (Verona) S.r.l.
Arizona State University
Arkansas Children's Hospital Research Institute
Armed Forces Institute of Pathology
Armed Forces Radiobiology Research Institute
Astellas Pharma Inc., Kashima Facilities
Astellas Pharma Inc., Tsukuba Research Center
Astellas Pharma Inc., Yaizu Technology Center
AstraZeneca Pharmaceuticals LP, AstraZeneca Pharmaceuticals LP, CNS Discovery
AstraZeneca Pharmaceuticals LP, AstraZeneca R&D Boston
AstraZeneca PLC, MedImmune UK Ltd
Atlanta University Center, Morehouse School of Medicine
Auburn University, College of Agriculture
Auburn University, College of Veterinary Medicine
Avanza Laboratories
AVEO Pharmaceuticals, Inc.
Aves Labs, Inc.
Axion Research Foundation, St. Kitts Biomedical Research Foundation
B. Braun Medical, Inc., B. Braun Medical, Inc-Biological Test Center
Baromedical Research Institute, Ltd.
BAS Bioanalytical Systems, Inc., BASi Evansville
BASF SE, Experimental Toxicology and Ecology
Battelle Memorial Institute, Battelle Northwest Operations
Battelle Memorial Institute-Columbus Operations
Baxter Healthcare Corporation, Technology Resources
Baxter Innovations GmbH - BioScience, Baxter BioScience
Baylor College of Medicine, Baylor College of Medicine and VAMC
Beckman Research Institute - City of Hope National Medical Center, Animal Resources Center
Beth Israel Deaconess Medical Center
BIOAGRI Laboratórios LTDA
Biocon Ltd., Syngene International Ltd.
BIOCON, Inc.
Bioculture Mauritius Ltd.
BioDuro (Beijing) Co., Ltd.
Biogen Idec, Inc., Biogen Idec, Inc.-Cambridge
Biogen Idec, Inc., Biogen Idec, Inc.-San Diego
Biogen Idec., Syntonix Pharmaceuticals, Inc.
BioLASCO Taiwan Co., Ltd., Yi-Lan Breeding Center
Biomedical Research Models, Inc.
Biomedical Sciences Institutes
Biomodels, LLC
BIOQUAL, Inc.
Bio-Quant Inc.
BioReliance Corporation
Bio-Source Farms, LLC
Biotoxtech Co. Ltd.
Boehringer Ingelheim Pharma GmbH & Co. KG
Boehringer Ingelheim Pharmaceuticals, Inc., R&D Animal Resources
Boehringer Ingelheim RCV GmbH & Co. KG
Borgess Medical Center, Borgess Research Institute
Boston Scientific, Boston Scientific, Research and Technology Center (RTC)
Boston University
Brandeis University
BRI Biopharmaceutical Research Inc.
Bristol-Myers Squibb Co, Research and Development - Hopewell
Bristol-Myers Squibb Co., Research and Development - Mount Vernon
Bristol-Myers Squibb Co., Research and Development - Princeton
Bristol-Myers Squibb Co., Research and Development - Syracuse
Bristol-Myers Squibb Co., Research and Development - Wallingford
Bristol-Myers Squibb Company, Research and Development - New Brunswick
Bristol-Myers Squibb R&D Company, Adnexus, a Bristol-Myers Squibb R&D Company
Brookhaven Science Associates, LLC, Brookhaven National Laboratory
Brown University
Buck Institute, Buck Institute for Age Research
Burleson Research Technologies, Inc.
Cadila Healthcare Limited, Zydus Research Centre
California Department of Public Health, California Department of Public Health - Richmond Laboratories
California Institute of Technology
California State Polytechnic University, College of Science and College of Letters, Arts and Social Sciences
Calvert Holdings, Inc. of Cary North Carolina, Calvert Laboratories, Inc.
Cardiovascular Research Foundation, Jack H. Skirball Center for Cardiovascular Research
Caritas St. Elizabeth's Medical Center at Boston
Case Western Reserve University, Case Western Reserve University School of Medicine
Cedars-Sinai Medical Center, Cedars-Sinai Medical Center Burns & Allen Research Institute
Center for Molecular Medicine and Immunology, Garden State Cancer Center
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention, Division of Vector-Borne Infectious Diseases
Centro de Investigación y Desarrollo Farmacéutico del Grupo Ferrer
Cephalon, Inc.
Charles R. Drew University of Medicine and Science
Charles River Laboratories, Piedmont Research Center
Charles River Laboratories Greater China Preclinical Services Shanghai Ltd.
Charles River Laboratories International, Inc., Charles River UK Limited
Charles River Laboratories Preclinical Services Montréal Inc.
Charles River Laboratories, Inc., Charles River Discovery and Imaging Services-Ann Arbor
Charles River Laboratories, Inc., Charles River Laboratories - Kingston
Charles River Laboratories, Inc., Charles River Laboratories - Portage
Charles River Laboratories, Inc., Charles River Laboratories - Raleigh
Charles River Laboratories, Inc., Charles River Laboratories - Wilmington
Charles River Laboratories, Inc., Charles River Laboratories, BRF
Charles River Laboratories, Inc., Charles River Laboratories, Inc. - Springborn
Charles River Laboratories, Inc., Charles River Laboratories, Preclinical Services, Nevada
Charles River Laboratories, Inc., Charles River Laboratories, Preclinical Services, Pennsylvania
Charles River Laboratories, Inc., Charles River Laboratories-Hollister, CA
Charles River Laboratories, Inc., Charles River Laboratories-San Diego
Charlotte-Mecklenburg Hospital Authority, Carolinas Medical Center
ChemOn Inc.
Children's Hospital, Research Institute for Children
Children's Hospital & Research Center Oakland, Children's Hospital Oakland Research Institute
Children's Hospital Boston
Childrens Hospital Los Angeles, The Saban Research Institute
Childrens Hospital Research Foundation
Children's Memorial Research Center
Children's Research Institute, Research Animal Facility
Chimp Haven, Inc.
Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Laboratory Animal Science
Chugai Pharmaceutical Co., Ltd.
Chulabhorn Research Institute
CIC bioGUNE, CIC bioGUNE Animal Unit
CIT
Clarian Health Partners, Inc., Methodist Research Institute
Clemson University
Cold Spring Harbor Laboratory
Colorado State University, Colleges of Veterinary Medicine and Biomedical Science, Natural Sciences, and Applied Human Sciences
Columbia University, Columbia University Medical Center
Continuum Health Partners, Inc., St. Luke's-Roosevelt Hospital Center
Cornell University - Ithaca Campus
Cornell University Medical College, Weill Medical College of Cornell University
Covance Inc., Covance Laboratories, Harrogate, UK, Ltd.
Covance Laboratories, Inc., Covance Laboratories Münster GmbH
Covance Laboratories, Inc., Covance Laboratories, Greenfield, IN
Covance Laboratories, Inc.
Covance Laboratories, Inc., Covance Laboratories, Inc.-Vienna
Covance Laboratories, Inc., Covance Madison
Covance Research Products, Inc., Covance Research Products, Inc. - VA
Covance Research Products, Inc., Covance Research Products, Inc.-Michigan
Creighton University
Crown Bioscience, Inc.
CRP-PA, Covance Research Products, Inc.
CRP-TX, Covance Research Products, Inc.
Crucell Holland B.V.
Dana-Farber Cancer Institute, Animal Resources Facility
Dartmouth College
DaVinci Biomedical Research Products
Department of Veterans Affairs, Atlanta Veterans Affairs Medical Center
Department of Veterans Affairs, Bay Pines Veterans Affairs Healthcare System
Department of Veterans Affairs, Central Arkansas Veterans Healthcare System
Department of Veterans Affairs, Cincinnati Veterans Affairs Medical Center
Department of Veterans Affairs, Clement J. Zablocki Veterans Affairs Medical Center
Department of Veterans Affairs, Coatesville VA Medical Center
Department of Veterans Affairs, Eastern Colorado Healthcare System
Department of Veterans Affairs, Edith Nourse Rogers Memorial Veterans Hospital
Department of Veterans Affairs, Edward Hines, Jr. Veterans Affairs Hospital
Department of Veterans Affairs, G.V. (Sonny) Montgomery VA Medical Center
Department of Veterans Affairs, Greater Los Angeles Healthcare System
Department of Veterans Affairs, Harry S. Truman Memorial Veterans Hospital
Department of Veterans Affairs, Hunter Holmes McGuire Veterans Affairs Medical Center
Department of Veterans Affairs, Huntington Veterans Affairs Medical Center
Department of Veterans Affairs, Iowa City Veterans Affairs Medical Center
Department of Veterans Affairs, James J. Peters Veterans Affairs Medical Center
Department of Veterans Affairs, Jesse Brown Veterans Affairs Medical Center
Department of Veterans Affairs, Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Department of Veterans Affairs, Louisville Veterans Affairs Medical Center
Department of Veterans Affairs, Memphis Veterans Affairs Medical Center
Department of Veterans Affairs, Miami Veterans Affairs Healthcare System
Department of Veterans Affairs, Minneapolis Veterans Affairs Medical Center
Department of Veterans Affairs, New Jersey Health Care System, Station 561
Department of Veterans Affairs, New York Harbor Healthcare System - Brooklyn Campus
Department of Veterans Affairs, North Florida/South Georgia Veterans Health System
Department of Veterans Affairs, Northport Veterans Affairs Medical Center
Department of Veterans Affairs, Palo Alto Health Care System
Department of Veterans Affairs, Philadelphia Veterans Affairs Medical Center
Department of Veterans Affairs, Portland Veterans Affairs Medical Center
Department of Veterans Affairs, Providence Veterans Affairs Medical Center
Department of Veterans Affairs, Ralph H. Johnson Veteran Affairs Medical Center
Department of Veterans Affairs, Salt Lake City Health Care System
Department of Veterans Affairs, Samuel S. Stratton VA Medical Center Animal Research
Department of Veterans Affairs, San Francisco Veterans Affairs Medical Center
Department of Veterans Affairs, Sioux Falls Veterans Affairs Medical Center
Department of Veterans Affairs, South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division
Department of Veterans Affairs, St. Louis Veterans Affairs Medical Center
Department of Veterans Affairs, Syracuse Veterans Affairs Medical Center
Department of Veterans Affairs, Tennessee Valley Healthcare System
Department of Veterans Affairs, VA Loma Linda Healthcare System
Department of Veterans Affairs, VA Pittsburgh Healthcare System
Department of Veterans Affairs, VA San Diego Healthcare System
Department of Veterans Affairs, VA Western New York Healthcare System
Department of Veterans Affairs, Veteran Affairs Boston Healthcare System
Department of Veterans Affairs, Veteran Affairs North Texas Health Care System
Department of Veterans Affairs, Veterans Affairs Ann Arbor Healthcare System
Department of Veterans Affairs, Veterans Affairs Connecticut Healthcare System
Department of Veterans Affairs, Veterans Affairs Medical Center
Department of Veterans Affairs, Veterans Affairs Medical Center
Department of Veterans Affairs, Veterans Affairs Medical Center
Department of Veterans Affairs, Veterans Affairs Medical Center
Department of Veterans Affairs, Veterans Affairs Medical Center
Department of Veterans Affairs, Veterans Affairs Puget Sound Health Care System
Department of Veterans Affairs, Washington DC VA Medical Center
Department of Veterans Affairs, White River Junction VA Medical
Department of Veterans Affairs, William Jennings Bryan Dorn Medical Center
Department of Veterans Affairs, William S. Middleton Memorial Veterans Hospital
Department of Veterans Affairs Medical Center, Charlie Norwood Veterans Affairs Medical Center
Deployment Medicine International
Des Moines University-Osteopathic Medical Center
Development Center for Biotechnology
Division of Ortho McNeil Pharmaceutical, Johnson & Johnson Pharmaceutical Research & Development, LLC-La Jolla
Division of Ortho-McNeil Pharmaceutical, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Duke University
Dwight D. Eisenhower Army Medical Center, Department of Clinical Investigation
E.I. duPont de Nemours & Co., DuPont Haskell Global Centers for Health and Environmental Sciences
East Carolina University
East Tennessee State University
Eastern Virginia Medical School
Edwards Lifesciences LLC
Eisai Co., Eisai, Inc.
Eli Lilly and Company
Eli Lilly and Company Ltd., Lilly Research Center
Ellegaard Göttingen Minipigs ApS
Elm Hill Breeding Labs
Emergent BioSolutions, Emergent BioDefense Operations Lansing
Emory University
Emory University, Yerkes National Primate Research Center
Ernest Gallo Clinic and Research Center
Ethicon, Inc.
Ethox International, STS
European Surgical Institute
Exelixis, Inc.
Exemplar Genetics, LLC, Exemplar Genetics, Lonestar Laboratory Swine
Experimur, LLC
Explora BioLabs, Inc.
Ferris State University
Florida A&M University
Florida State University, Laboratory Animal Resources
Fox Chase Cancer Center, Institute for Cancer Research
Fred Hutchinson Cancer Research Center
Frontier BioMedical, LLC
Gachon University of Medicine and Science, Lee Gil Ya Cancer and Diabetes Institute
Galápagos NV, Galápagos istrazivacki centar d.o.o.
Geisinger Clinic, Weis Center for Research, Geisinger Clinic
Genentech, Inc.
General Electric Global Research Center
GenScript Corporation
Genzyme Corporation, Genzyme - Oklahoma City
Genzyme Corporation
Georgetown University
Gilead Sciences
GlaxoSmithKline, GlaxoSmithKline R&D S.L.
GlaxoSmithKline Corporation, GlaxoSmithKline Biologicals, Rixensart, Belgium
GlaxoSmithKline Inc.
GlaxoSmithKline Pharmaceuticals plc, GlaxoSmithKline Pharmaceuticals Research & Development UK
GlaxoSmithKline Pharmaceuticals, R&D
GTC Biotherapeutics
Guangxi Weimei Bio-tech Co., Ltd.
GVK Biosciences Private Limited
Hainan Jingang Biotech Co. Ltd, Hainan Jingang Biotech Co. Ltd.
HAMRI Co., Ltd., Testing and Research Laboratories
Harlan Laboratories Inc., Harlan Laboratories Ltd., Füllinsdorf and Itingen
Harlan Laboratories, Inc, Harlan Laboratories, Inc.- Indianapolis, Indiana
Harlan Laboratories, Inc., Harlan Laboratories Inc. - Houston, TX
Harlan Laboratories, Inc.
Harlan Laboratories, Inc., Harlan Laboratories, Inc. - Dublin, Virginia
Harlan Laboratories, Inc., Harlan Laboratories, Inc. - Frederick, MD
Harlan Laboratories, Inc., Harlan Laboratories, Inc. - Haslett, Michigan
Harlan Laboratories, Inc., Harlan Laboratories, Inc. - Somerville, NJ
Harry Pearlman Biomedical Research Institute, Mount Sinai Medical Center
Hartford Hospital
Harvard University, Harvard Medical Area
Harvard University, Harvard University/Faculty of Arts & Sciences
HD Biosciences Co., Ltd.
HealthPartners, Inc., HealthPartners Research Foundation
Hematech, Inc.
Hennepin Faculty Associates, Minneapolis Medical Research Foundation
Henry Ford Health System
Hoffmann-La Roche Inc.
Hokkaido University, School of Veterinary Medicine
Hospital for Special Surgery
Howard Hughes Medical Institute, Janelia Farm Research Campus
Howard University, College of Medicine
Hunter College
Huntingdon Life Sciences Group plc, Huntingdon Life Sciences, Ltd.
Huntingdon Life Sciences Inc., Huntingdon Life Sciences, Inc. (PRC)
Huntington Medical Research Institutes
Idaho State University
IIT Research Institute, Life Sciences Group
Immune Disease Institute
Ina Research Inc., Ina Research Inc., Testing Facility
INA Research Philippines, INARP-LTI and Primate Quality Control Center
Indiana University, School of Dentistry
Indiana University-Purdue University at Indianapolis, Purdue University School of Science
Indiana University-Purdue University at Indianapolis, School of Medicine
INRS-Institute Armand-Frappier, Experimental Biology Centre
Institut d’Investigació Biomedica de Bellvitge (IDIBELL) (IDIBELL), Institut d’Investigació Biomedica de Bellvitge (IDIBELL (IDIBELL)
Institut de Recherche Pierre Fabre, Centre de Recherche Pierre Fabre
Institute for Systems Biology
Integrated Laboratory Systems, Inc.
Isis Pharmaceuticals, Inc.
ISIS Services, LLC
ITR Laboratories Canada Inc.
Jai Research Foundation
Johns Hopkins University
Johnson & Johnson, Ethicon Endo-Surgery, Inc.
Johnson & Johnson, Johnson & Johnson MEDICAL GmbH
Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, LLC
Johnson & Johnson, Johnson & Johnson Pharmaceutical Research and Development, a division of Janssen Pharmaceutica N.V.
Johnson and Johnson, Ortho-Clinical Diagnostics, Inc.
Joinn Laboratories
Kansas State University, College of Veterinary Medicine and College of Human Ecology
Kent State University, College of Arts and Sciences
KHI Group Hong Kong, Nafovanny Vietnam (Vietnam Primate Breeding and Development Corporation)
Korea Institute of Toxicology
Korean Animal Technology (KOATECH)
Kunming Primate Research Center, Chinese Academy of Sciences
LAB Research Inc., LAB International Research Center Hungary Ltd.
LAB Research Inc., LAB Research Inc. - Canada
LaJolla Institute for Allergy and Immunology
Lake Immunogenics, Inc.
Lampire Biological Laboratories, Inc.
Lantheus Medical Imaging Inc.
Lawrence Berkeley National Laboratory
Lawrence Livermore National Laboratory
Legacy Clinical Research and Technology Center, Legacy Health System
Level Biotechnology Inc.
Lexicon Pharmaceuticals, Inc.
Liberty Research, Inc.
Lifespan, The Rhode Island and Miriam Hospitals
Loma Linda University
Lonza Group Ltd., Lonza Walkersville, Inc.
Los Alamos National Security, LLC, Los Alamos National Laboratory
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed)
Louisiana State University, Louisiana State University Health Sciences Center
Louisiana State University, School of Veterinary Medicine
Louisiana State University Agricultural Center, Louisiana Agricultural Experiment Station, Reproductive Biology Center
Louisiana State University Health Sciences Center
Louisiana State University System, Pennington Biomedical Research Center
Lovelace Respiratory Research Institute
Loyola University Chicago, Stritch School of Medicine
LyChron, LyChron, LLC
M. D. Anderson Cancer Center Orlando, Cancer Research Institute
Maccine Pte Ltd
Maccine Pte Ltd, PT Mac Fauna
Madigan Army Medical Center, Department of Clinical Investigation
Magee-Womens Research Institute
Maimonides Medical Center, Division of Surgical Research
Maine Medical Center, Maine Medical Center Research Institute
MannKind Corporation
Marquette University
Marshall Farms Group, Ltd., Marshall BioResources
Marshall University Joan C. Edwards School of Medicine, Animal Resource Facility
Massachusetts College of Pharmacy and Health Sciences
Massachusetts Institute of Technology
Mayo Foundation, Mayo Clinic Jacksonville
Mayo Foundation, Mayo Clinic Rochester
Mayo Foundation, Mayo Clinic Scottsdale
MB Research Laboratories
McLaughlin Research Institute for Biomedical Sciences, Inc.
Medarex, Inc.
Medical College of Georgia
Medical College of Wisconsin
Medical University of South Carolina
Medicilon Preclinical Research, LLC and MPI Research, Inc., Medicilon/MPI Preclinical Research-Shanghai
MedImmune, LLC
MedImmune, LLC
Medine Sugar Estates, Biodia Co. Ltd.
MedStar Health, MedStar Research Institute
Medtronic, Inc., Physiological Research Laboratories
Meharry Medical College
Memorial Sloan-Kettering Cancer Center
Merck & Co., Inc., Merck Research Laboratories - Boston
Merck & Co., Inc., Sirna Therapeutics, Inc.
Merck & Company, Merck Research Laboratories-Kenilworth
Merck & Company, Inc., Laboratoires Merck Sharp and Dohme-Chibret
Merck and Company, Schering Corporation
Merck and Company, Inc., Merck Research Laboratories
Merck and Company, Inc., Merck Research Laboratories-West Point
Merck Frosst Canada & Co., Merck Frosst Centre for Therapeutic Research
Merck KGaA, Darmstadt, Germany, Merck Serono SA Geneva
Merieux Alliance Group, Advanced BioScience Laboratories, Inc.
Michigan State University
Midwest Research Institute
Midwestern University
Millbrook ImmunoServ
Mispro Biotech Services Inc.
Mississippi State University, College of Arts and Sciences
Mississippi State University, College of Veterinary Medicine
Model Animal Research Center of Nanjing University
Molecular Diagnostic Services, Inc., Rabbit and Rodent Diagnostic Associates
Momenta Pharmaceuticals, Inc.
Montana State University, College of Letters and Science
MPI Research
NAMSA-Ohio Division
Nanospectra Biosciences, Inc.
NASA John F. Kennedy Space Center, Space Life Sciences Laboratory
National Aeronautics and Space Administration, LB Johnson Space Center Animal Care Facility
National Applied Research Laboratories, National Laboratory Animal Center
National Applied Research Laboratories, National Laboratory Animal Center in Tainan
National Cancer Institute, National Cancer Institute-Frederick
National Defense Medical Center, NDMC-Laboratory Animal Center
National Institute for Occupational Safety and Health, Health Effects Laboratory Division
National Institute for the Control of Pharmaceutical and Biological Products, National Center for Safety Evaluation of Drugs
National Institute of Environmental Health Sciences
National Institutes of Health, Alamogordo Primate Facility
National Institutes of Health, National Institute on Aging, Baltimore
National Institutes of Health-National Institute on Drug Abuse, Intramural Research Program
National Jewish Health
National Shanghai Center for New Drug Safety Evaluation and Research
National University of Singapore
Naval Medical Research Center, Naval Medical Research Center Detachment-Peru
Naval Medical Research Center, U.S. Naval Medical Research Unit #3
Nebraska-Western Iowa Health Care System
Nevada Cancer Institute
New Mexico Veterans Affairs Health Care System
New York Blood Center, Lindsley F. Kimball Research Institute, New York Blood Center
New York Medical College, New York Medical College-Department of Comparative Medicine
New York State Department of Health, Wadsworth Center
New York University, The Mount Sinai School of Medicine
New York University School of Medicine
NIH/National Institute of Allergy and Infectious Diseases, Rocky Mountain Laboratories
North Carolina Central University
North Carolina Research Campus
North Carolina State University, College of Veterinary Medicine
North Shore-Long Island Jewish Health System, The Feinstein Institute for Medical Research
Northeastern Ohio Universities College of Medicine
Northeastern University
Northern Biomedical Research, Inc.
NorthShore University HealthSystem, NorthShore University HealthSystem Research Institute
Northwestern University
Norwegian School of Veterinary Science, Alestrom Zebrafish Lab
Norwegian School of Veterinary Science, Laboratory Animal Unit
Novartis Corporation, Novartis Vaccines and Diagnostics, Inc.
Novartis Pharmaceuticals Corporation, Novartis Institutes of Biomedical Research
Novartis Vaccines and Diagnostics GmbH & Co. KG, Novartis Behring
Noveprim Ltd., Noveprim Ltd. (includes Le Campêches Ltd. And Chamouny Farming Ltd.)
Nucro-Technics
Oak Ridge National Laboratory
Oakland University
Ochsner Clinic Foundation
Ohio University
Oklahoma Medical Research Foundation
Oklahoma State University, Center for Veterinary Health Sciences
OncoMed Pharmaceuticals, Inc.
Oregon Health and Science University
Oregon Health and Science University, Oregon National Primate Research Center
OSI Pharmaceuticals, Inc.
Pacific BioLabs, Inc.
Pacific Northwest Diabetes Research Institute
Palo Alto Medical Foundation, Research Institute
Parc de Recerca Biomèdica de Barcelona
Peking University, Institute of Molecular Medicine
Pfizer Global Research & Development
Pfizer Global Research and Development, Pfizer Global Manufacturing, Lincoln, Nebraska
Pfizer Inc., Pfizer Animal Health, Veterinary Medicine Research and Development
Pfizer Inc., Pfizer Canada Inc., Vaccines Research Ottawa Laboratories
Pfizer, Inc., Pfizer Animal Health
Pfizer, Inc., Pfizer Global Research & Development, La Jolla
Pfizer, Inc., Pfizer Global Research and Development, Groton
Pfizer, Inc., Pfizer, Inc. - Pearl River
PharmaLegacy Laboratories (Shanghai) Co., Ltd
Pharmaron, Inc., Pharmaron (Beijing), Inc.
Pharmaron, Inc., Pharmaron, Inc. (formerly Vital Bridge (China) Inc.)
Philadelphia Health and Education Corporation, Drexel University and Drexel University College of Medicine
Philip Morris International, Philip Morris Research Laboratories bvba
Pine Acre Rabbitry/Farm
Pocono Rabbit Farm and Laboratory, Inc.
Pomona College
Portola Pharmaceuticals, Inc.
PreClinOmics, Inc.
Primate Products, Inc.
Primate Research Center at Bogor Agricultural University, Research Animal Facility - Lodaya
Princeton University
Product Safety Labs
Public Health Service, Department of Health and Human Services, NIH Intramural Research Program
Purdue University, Indiana University/Purdue University-Ft. Wayne
Purdue University
PWG Genetics Pte. Ltd.
QPS, L.L.C.
Research Triangle Institute, Research Triangle Institute (RTI International)
Ricerca Biosciences, LLC, Ricerca Biosciences S.A.S.
Ricerca Biosciences, LLC, Toxicology and Metabolism and Pharmacokinetics
Roche Holding Ltd., Roche Pharma Basel
Rosalind Franklin University of Medicine and Science
Roswell Park Cancer Institute Corporation
Rush University Medical Center
Russian Academy of Sciences, Animal Breeding Facility-Branch of Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry
Russian Academy of Sciences, Biological Testing Laboratory-Branch of Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry
Rutgers, The State University of New Jersey
Saint Joseph's Health System, Saint Joseph's Translational Research Institute, Inc.
Saint Louis University, Saint Louis University School of Medicine
Salus University
Samsung Medical Center, Samsung Biomedical Research Institute
Sanofi Pasteur
sanofi-aventis, Sanofi Pasteur Limited
sanofi-aventis, sanofi-Aventis Deutschland GmbH - Biological Quality Control
sanofi-aventis, sanofi-aventis Deutschland GmbH, Industriepark Höchst
sanofi-aventis, sanofi-aventis Deutschland GmbH, Kastengrund
sanofi-aventis, sanofi-aventis R &D Porcheville, France
sanofi-aventis, sanofi-aventis, Alfortville, France
sanofi-aventis, sanofi-aventis, Alnwick, England
sanofi-aventis, sanofi-aventis, Bridgewater, New Jersey
sanofi-aventis, sanofi-aventis, Vitry, France
sanofi-aventis Milan Research Centre
sanofi-aventis Science & Medical Affairs, LASW, CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd.
Scantibodies Laboratory, Inc., Laboratorios Scantibodies, S.A. de C.V.
Schepens Eye Research Institute
Scott and White Memorial Hospital, Scott & White Memorial Hospital
Scripps Institutions of Medicine and Science, The Scripps Research Institute
SDIX
SDIX
Seattle Children's Hospital and Regional Medical Center, Seattle Children's Research Institute
Seoul National University Hospital, Clinical Research Institute
Sequani Limited
ShangPharma Co., Ltd., Shanghai ChemPartner Co., Ltd.
Shenyang Research Institute of Chemical Industry, Safety Evaluation Center
Shire Pharmaceuticals, Shire Human Genetic Therapies
Shriners Hospitals for Children, Shriners Burns Hospital-Cincinnati
SICONBREC, Inc.
Siemens Healthcare Diagnostics, Inc.
Sigma Advanced Genetic Engineering (SAGE Labs), Ace Animals, Inc.
Simonsen Laboratories, Inc.
Sinclair Group, LLC, Sinclair Research Center, LLC; Sinclair BioResources, LLC; Pet Food Solution, Inc.
Singapore Health Services Pte Ltd, SingHealth Experimental Medicine Centre
Smith College
SNBL USA, Ltd.
Southern Arizona Veterans Affairs Health Care System
Southern Illinois University, Graduate School, Southern Illinois University at Carbondale
Southern Illinois University, School of Medicine
Southern Research Institute, Southern Research Institute-Birmingham, AL and Frederick, MD
Southwest Foundation for Biomedical Research
Space and Naval Systems Center (SSC San Diego)
Spectrum Health Hospitals and Calvin College, West Michigan Regional Laboratory
Spring Point Project
Spring Valley Laboratories, Inc.
SRI International
St. John's University
St. Joseph's Hospital and Medical Center
St. Jude Children's Research Hospital
Stanford University
State University of New York, Binghamton University
State University of New York, Downstate Medical Center
State University of New York, Stony Brook University
State University of New York, SUNY Upstate Medical University
State University of New York at Buffalo
STILLMEADOW, Inc.
Stowers Institute for Medical Research
Sugi Institute of Biological Science Co., Ltd.
Summa Health System, Falor Division of Surgical Research
Sun Health Research Institute
Sun Pharma Industries Ltd., Sun Pharma Advanced Research Company Ltd.
Sungkyunkwan University, Sungkyunkwan University School of Medicine
Surpass, Inc.
Sutter Health System, Sutter Institute for Medical Research
Synecor Labs
Syracuse University
Taconic Europe A/S
Taconic Farms, Inc.
Taconic Farms, Inc., Taconic Indiana
Taconic Farms, Inc., Taconic Rockville
Taconic Farms, Inc., Taconic West Coast Operations
Taconic Farms, Inc., TaconicArtemis GmbH
Taconic Farms, Inc., Xenogen Biosciences, Inc.
Takeda Pharmaceutical Company Limited, Millennium: The Takeda Oncology Company
Takeda Pharmaceutical Company Ltd., Takeda San Francisco
Talecris Biotherapeutics
Temple University, Health Science Center
Texas A&M Health Science Center - Houston, Albert B. Alkek Institute of Biosciences and Technology
Texas A&M University, Colleges of Veterinary Medicine, Science, and Liberal Arts
Texas A&M University System, Texas A&M Health Science Center/College of Medicine
Texas Heart Institute
Texas Tech University
Texas Tech University Health Sciences Center
TGA Sciences, Inc.
The American Red Cross, The Jerome H. Holland Laboratory for the Biomedical Sciences
The Burnham Institute for Medical Research
The Children's Hospital of Philadelphia Research Institute
The Cleveland Clinic Foundation, Lerner Research Institute
The Dow Chemical Company, Toxicology & Environmental Research and Consulting Laboratory
The First Affiliated Hospital of XinJiang Medical University
The Forsyth Institute
The General Hospital Corporation, Massachusetts General Hospital
The George Washington University
The Hamner Institutes for Health Sciences
The Hebrew University
The Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, the Chinese People's Liberation Army, National Beijing Center for Drug Safety Evaluation and Research
The Jackson Laboratory
The Jackson Laboratory-West
The Lankenau Institute for Medical Research
The Mannheimer Foundation, Inc.
The Mary Imogene Bassett Hospital, The Mary Imogene Bassett Research Institute
The Methodist Hospital, The Methodist Hospital Research Institute
The Ohio State University, University Laboratory Animal Care Program and Facilities
The Pennsylvania State University, Milton S. Hershey Medical Center
The Pennsylvania State University-University Park, The Pennsylvania State University
The Procter and Gamble Company, Miami Valley Innovation Center and Mason Business Center
The Research and Education Institute for Texas Health Resources
The Research Institute at Nationwide Children’s Hospital, The Research Institute at Nationwide Children's Hospital
The Rockefeller University
The Rogosin Institute, The Rogosin Institute - Xenia Division
The Roskamp Institute
The Salk Institute for Biological Studies
The Scripps Research Institute, The Scripps Research Institute, Florida
The START Center for Cancer Care, South Texas Accelerated Research Therapeutics (START)
The University of Alabama
The University of Alabama at Birmingham and VAMC
The University of Arizona
The University of Chicago
The University of Georgia, University Research Animal Resources
The University of Hong Kong, Laboratory Animal Unit, Li Ka Shing Faculty of Medicine
The University of Illinois at Chicago
The University of Kansas
The University of Mississippi, Oxford Campus
The University of Montana
The University of Pennsylvania, The University of Pennsylvania School of Medicine
The University of Tennessee
The University of Tennessee Health Science Center
The University of Texas, M.D. Anderson Cancer Center
The University of Texas at Austin
The University of Texas Health Science Center at Houston, Center for Laboratory Animal Medicine and Care
The University of Texas Health Science Center at San Antonio
The Wistar Institute
Therapeutic Systems Research Laboratories, Inc.
Theravance, Inc.
Thomas D. Morris, Inc.
Thomas Jefferson University
Toxikon Corporation
TransPharm Preclinical Solutions, LLC
Tripler Army Medical Center
Trudeau Institute, Inc.
Tufts University, Cummings School of Veterinary Medicine
Tufts University, Tufts University Health Science Campus and Tufts-New England Medical Center
Tulane University, Tulane National Primate Research Center
Tulane University, Tulane University School of Medicine
Tulane University, Tulane University Uptown Vivarium
Tyco Healthcare Group LP (DBA-Covidien)
U.S. Air Force Academy, Dean of Faculty
U.S. Air Force Keesler Medical Center, Clinical Research Laboratory
U.S. Air Force Wilford Hall Medical Center, Clinical Research Division
U.S. Army Center for Environmental Health Research
U.S. Army Institute of Surgical Research/Brooke Army Medical Center
U.S. Army Medical Research and Material Command, U.S. Army Medical Research Institute of Infectious Diseases
U.S. Army Medical Research Institute of Chemical Defense
U.S. Army Public Health Command (Provisional)
U.S. Army Research Institute of Environmental Medicine
U.S. Army, Academy of Health Sciences, U.S. Army Medical Department Center and School
U.S. Department of Agriculture, National Veterinary Services Laboratories/Center for Veterinary Biologics
U.S. Department of Agriculture - Agricultural Research Service, Beltsville Human Nutrition Research Center
U.S. Department of Agriculture at Tufts University, The Jean Mayer USDA Human Nutrition Research Center on Aging
U.S. Environmental Protection Agency, Andrew W. Breidenbach Environmental Research Center
U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory
U.S. Food and Drug Administration, Center for Biologics Evaluation & Research, Division of Veterinary Sciences
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration, National Center for Toxicological Research
U.S. Food and Drug Administration, White Oak Animal Program
U.S. Naval Medical Center-Portsmouth, Clinical Investigation and Research Department
U.S. Navy, Naval Medical Center-San Diego
Uniformed Services University of the Health Sciences
Union University, The Albany Medical College
University of Arkansas at Little Rock
University of Arkansas for Medical Sciences
University of California, Merced
University of California, San Francisco
University of California, Santa Cruz
University of California-Berkeley
University of California-Davis
University of California-Irvine, University Laboratory Animal Resources
University of California-Los Angeles, Division of Laboratory Animal Medicine
University of California-Riverside
University of California-San Diego
University of Cincinnati
University of Colorado at Denver and Health Sciences Center
University of Connecticut Health Center
University of Connecticut, Storrs
University of Copenhagen and National University Hospital, Department of Experimental Medicine
University of Denver (Colorado Seminary)
University of Florida, J. Hillis Miller Health Science Center
University of Houston
University of Illinois at Chicago, College of Medicine at Rockford
University of Illinois at Urbana-Champaign
University of Iowa
University of Kansas, The University of Kansas Medical Center
University of Kentucky, University of Kentucky Albert B. Chandler Medical Center
University of Louisiana at Lafayette, New Iberia Research Center
University of Louisville
University of Maine System, College of Engineering, University of Maine
University of Maryland at Baltimore, Dental School
University of Maryland at Baltimore, School of Medicine, Institute of Human Virology and VAMC
University of Maryland at Baltimore, School of Pharmacy
University of Massachusetts Medical School
University of Medicine and Dentistry of New Jersey, New Jersey Medical School
University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School
University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine
University of Miami
University of Michigan
University of Minnesota
University of Mississippi, University of Mississippi Medical Center
University of Missouri-Columbia, School of Medicine, Dalton Cardiovascular Center, Colleges of Arts and Science and Veterinary Medicine, and Bond Life Sciences Center
University of Missouri-Kansas City
University of Missouri-St. Louis
University of Nebraska at Omaha
University of Nebraska Medical Center
University of Nevada, Reno
University of Nevada-Las Vegas
University of New Mexico, The University of New Mexico Health Sciences Center
University of North Carolina at Chapel Hill
University of North Carolina at Charlotte
University of North Dakota Center for Biomedical Research, College of Arts and Sciences
University of North Dakota Center for Biomedical Research, School of Medicine
University of North Texas Health Science Center
University of Notre Dame, Freimann Life Science Center and Satellite
University of Oklahoma Health Sciences Center
University of Oregon
University of Pittsburgh, Commonwealth System of Higher Education
University of Puerto Rico, Medical Sciences Campus, Caribbean Primate Research Center
University of Puerto Rico, Medical Sciences Campus
University of Rochester, School of Medicine and Dentistry
University of South Alabama, College of Medicine
University of South Carolina - Columbia
University of South Dakota
University of Southern California
University of Texas M.D. Anderson Cancer Center, Michale E. Keeling Center for Comparative Medicine and Research
University of Texas M.D. Anderson Cancer Center, Science Park Research Division, Department of Carcinogenesis
University of Texas Southwestern Medical Center at Dallas
University of Texas Systems, University of Texas Medical Branch-Galveston
University of Texas-San Antonio
University of the Sciences in Philadelphia
University of Toledo, University of Toledo Health Science Campus
University of Utah, Department of Biology, College of Science
University of Utah, Health Sciences Center and College of Social and Behavioral Sciences
University of Vermont, Colleges of Medicine, Arts & Sciences, and Engineering & Mathematical Sciences
University of Virginia
University of Washington
University of Wisconsin - Madison, School of Veterinary Medicine
University of Wisconsin - Oshkosh College of Letters and Science
University of Wisconsin System, University of Wisconsin-Milwaukee
University of Wisconsin-La Crosse, College of Science and Health
University of Wisconsin-Madison, College of Agricultural and Life Sciences
University of Wisconsin-Madison, Graduate School
University of Wisconsin-Madison, University of Wisconsin School of Medicine and Public Health
Utah State University, College of Science
Utrecht University, Central Laboratory Animal Institute
Valley Biosystems
Van Andel Institute, Van Andel Research Institute
Vanderbilt University
Virginia Commonwealth University
Virginia Mason Health System, Benaroya Research Institute at Virginia Mason
Virginia Polytechnic Institute and State University, Virginia-Maryland Regional College of Veterinary Medicine and Marion DuPont Scott Equine Medical Center
ViviSource Laboratories, Inc.
Wake Forest University, Wake Forest University School of Medicine
Walter Reed Army Institute of Research, U.S. Army Medical Component-Armed Forces Research Institute of Medical Sciences
Walter Reed Army Institute of Research and Naval Medical Research Center
Washington State University
Washington University School of Medicine & Wash University Danforth Campus
Wayne State University and John D. Dingell VA Medical Center
Weizmann Institute, Weizmann Institute of Science
Wellesley College
WestChina Frontier Pharmatech and Chengdu Frontier BioSciences, The National Chengdu Center for Safety Evaluation of Drugs
Wichita State University, Department of Biological Sciences
WIL Research Holding Company, Inc., WIL Research Laboratories, LLC
William Beaumont Army Medical Center, Biological Research Service
William Beaumont Hospital Research Institute, William Beaumont Hospital
Wincon TheraCells Biotechnologies Co., Ltd.
Winthrop University Hospital, Comparative Medicine Division
Wright State University
Wright-Patterson Air Force Base, Air Force Research Laboratory
Wuhan University, Center for Animal Experiment of Wuhan University, China
WuXi AppTec
WuXi AppTec Ltd., Safety Evaluation Center, WuXi AppTec (Suzhou) Co., Ltd.
WuXi AppTec, Inc.
Wyeth, European Drug Safety & Metabolism Research Center-Wyeth Lederle S.p.A.
Wyeth, Wyeth Research, Massachusetts
Wyeth Research, Wyeth Research-Princeton
XenoBiotic Laboratories, Inc., XBL-China, Inc.
XenoBiotic Laboratories, Inc.
XOMA (US) LLC
Yale University
Yeshiva University, Albert Einstein College of Medicine
Yonsei University, College of Medicine
ZymoGenetics, Inc

6 MONTH PART-TIME DIPLOMA IN PHARMA REGULATORY AFFAIRS

Academy of Intellectual Property Studies is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.

Introduction to Regulatory Affairs
Good Manufacturing Practices, QA and Regulation
ICH
Dossier preparation and CTD Compilation
Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World
Clinical Investigational Studies
Pharma Patents, IPR and Regulation
Electronic Submissions

To register, please e-mail info@aips.ac.in

Get emails on banned drugs.

How about getting emails on drugs that are banned in India? Yes, it is possible if you are registered Pharmacist in Karnataka.

The Karnataka State Pharmacy Council (KSPC) is collecting the email IDs of new as well existing members so that it can disseminate information about drugs as quickly as possible. KSPC registrar B S Bhagwan said, “The email service will work as an internal circular among registered pharmacists. For instance, if a drug is banned, or crucial information about a drug has to be passed on, this is the most effective way. We can also pass on research information.” Though providing email IDs is not mandatory, Bhagwan said that it could be a disadvantage since such information would not be sent through post. “They will have to depend on other sources of information, like circulars from the drug control department and newspapers,” he said.

This service is expected to start in a few months. The council plans to begin the service once it finishes collecting email IDs and that should take a few months. KSPC president D A Gundu Rao said though the service was optional, they were willing to help those without an email ID to create one. The state has 44002 as of 12th October 2010.

Highlight of Indian Pharmacopoeia 2010

One of the important mandates of the Indian Pharmacopoeia Commission is to publish the Indian Pharmacopoeia (legally recognized book of standards for monitoring the quality of drugs and pharmaceuticals as per the Drugs and Cosmetics Act, 1940) at regular and shorter intervals. To fulfill this requirement, the 6th edition of Indian Pharmacopoeia has been prepared by the Commission in accordance with the principles and designed plan decided by its Scientific Body and completed through the untiring efforts of its members and Secretariat over a period of about two years.

Highlights Of the Indian Pharmacopoeia 2010:

1. Presented in 3 hard bound volumes
2. Total monographs 1918 out of which 287 are added first time
3. Category of a drug, dosage and usual available strength of dosage forms added
4. Classical chemicals tests for identification of an article have been almost eliminated and more specific IR and UV Spectrophotometric tests have been introduced
5. Cross referencing has been avoided
6. Veterinary products monographs are the integral part of this edition
7. Uniformity of presentation of subject matter
8. Use of chromatographic methods has been greatly extended
9. Test for pyrogen virtually eliminated
10. More herbal drugs monographs has been added
11. Contains several new monographs not in any major pharmacopoeias of the world
12. Authenticity Certificate
13. User friendly format

Additional links about Indian Pharmacopoeia 2010.

Release of Indian Pharmacopoeia -2010

GVK Biosciences receives AAALAC Accreditation

GVK Biosciences Private Limited (GVK BIO), Asia’s leading Contract Research Organization today announced that it received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International for its animal facilities.

The accreditation demonstrates GVK BIO’s commitment to high standards of animal care. AAALAC commended the organization for promoting a productive research environment that ensured high standards of humane care and use of research animals.

The AAALAC certification will help in furthering GVK BIO’s growth in the areas of Pharmacology, ADME/DMPK, Exploratory toxicology and Animal Models. GVK BIO is the first organization in Hyderabad and only the 6th one in India to receive AAALAC certification. The endorsement is a validation of GVK BIO’s abilities to deliver world class solutions.

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Funny Clinical Research Cartoons

Alzheimer's - Funny

PHARMaceutical EXPO 2010

PHARMaceutical EXPO 2010 is organized by Federation of Indian Chamber of Commerce and Industry concurrent with the 62nd Indian Pharmaceutical Congress at Manipal, Karnataka from December 17-19, 2010.

PHARMaceutical EXPO 2010 provides an opportunity to the participating companies to display their products and services to the business visitors provided by the show. The event will be attended by more than 8000 delegates including the CEOs and top executives of the Pharmaceutical Industry, Officers from Regulatory Departments, Pharmacists from trade and profession, Research and Development personnel, Pharmaceutical Consultants, Hospital Administration, Top officials of Central and state agencies, Academicians and Teachers from Medical and Pharmacy Colleges.

Objectives:

Project the latest technological developments in pharmaceuticals, drugs and formulations.
Project the status, facilities and services on R & D, quality control, Govt. regulations and controls, rules and procedures.
Supply of plant, machinery, process control equipment, projects and services etc.

Showcase the latest products, machinery, equipment developments in the industry for generating business and test marketing
Technology adaptation and up gradation
Joint venture partnership, project collaborations, transfer of technology, investments and R & D

Bioph -India 2010 -Bio Solutions for Pharma

December 01-03, 2010
Bombay Exhibition Centre, Mumbai

After the successful introduction in 2007 of the Biotech Zone, the Bio trail @ CPhI and the Bio Production Breakfast seminar in Frankfurt 2008, CPhI India has now introduced BioPh India: Bio-Solutions for Pharma.All companies and organizations dealing with the research and development of new treatment methods made through biotechnological processes or which are derived from or use live organisms will benefit from the mix of exhibition, seminars and 121 partnering meetings at BioPh. Hosting such an event alongside CPhI India ICSE India and P-MEC India offers a plethora of networking and commercial opportunities, creating a perfect synergy in the world of drug research and manufacturing.

One day Seminar on Bioequivalence

Bioequivalence Studies are a commonly accepted method to demonstrate the therapeutic equivalence between two competing drugs, and form an essential part of the drug registration dossier. Using bioequivalence as a tool to introduce a new generic drug into the market can lead to significant reductions in both the time and costs involved, with the result that the design, performance and evaluation of the related bioequivalence studies have become critical in the drug development process in the pharmaceutical industry. The one day interactive Seminar on Bioequivalence being offered by AIPS will lead to an understanding of the planning, conducting, analyzing and reporting of BE Studies, and will be suitable for professionals in the drug development R&D, regulatory, clinical, medical etc functions.

e-mail : info@aips.ac.in

International Conference on Clinical Trials

Clinical research is an indispensable phase in drug development process to evaluate the efficiency and safety of drug. The process is highly specialized and involves huge investments to introduce new drug capable of curing the ailments.Indian CRO industry is competitive enough to conduct trials to meet the global standards. It is felt that there should be robustness in the IRB and regulatory mechanism so that the clinical trial data generated in India is well accepted globally.

Objectives:

•To create a platform for deliberation on creating conducive regulatory for clinical research to meet global standards.

•To showcase the competitiveness of Indian Clinical Research industry to the International stakeholders and also to facilitate meaningful interactions for possible joint ventures. Key learnings

•Learning of grounding economic and operational realities in conducting international trials. •Creation of working environment that is flexible enough to deal with the regulatory requirements.

•Best practices in global recruitment strategy and how best they can be applied in different regions.

Start Date: Nov 19, 2010, End Date: Nov 20, 2010
Venue: Intercontinental The Lalit Mumbai, Magestic Hall, Sahar Airport Road, Andheri (East), Mumbai Maharashtra India

Contacts :
Ravikiran Veligeti [Executive Officer ]
Confederation of Indian Industry
CII Knowledge & Innovation Initiatives
3rd Floor, IGSSS Building
28, Instutional Area
Lodi Road
New Delhi-110003
Delhi India
Phone : 91-11-45772019
Fax :91-11-45772014
Email : ravikiran.v@cii.in