ICT with DPST & UGC-CAS to organise 2-day symposia on nanomedicine

Institute of Chemical Technology (ICT), Mumbai in collaboration with the Department of Pharmaceutical Sciences and Technology (DPST) and the UGC Centre of Advanced Studies (UGC-CAS) is organising a two day Indo-US joint symposia on nanomedicine: Its prospects and challenges from November 14 – 15, 2011 at ICT campus.

Nanomedicine, is a concept originated from India. In Ayurveda, the use of Bhasmas is still popular which is a form of nanomedicine. The modern medicine has realized the potential of nanomedicine to reduce the dose, toxicity and for its targeting potential worldwide.

The nanomedicine is used for diagnostics and therapeutics of cancer, neurodegeneratives, tuberculosis, malaria and other infectious diseases is established and a thrust area of research. Many nanotechnology products based on immunomodulator formulations are in clinical use.

Prof Vandana B Patravale, professor of pharmaceutics, DPST and ICT, Mumbai said that this will be the first time where India and US will come together and this collaboration is expected to foster between the US and Indian investigators and it will be academia-academia, industry-industry collaboration.

“It will be beneficial for Indian consumers as the high end technologies could be identified with drug delivery systems, and devices. This could be the key feature to drive growth of pharmaceutical and medical sectors into cost effective, patient compliant, safe yet superior products for Indian market,” further she added.

This symposia will target biomedical engineers, pharmaceutical and clinical researchers, clinicians as well as graduate and post doctorate fellows and research scientists from both academia and industry who have an interest in nanomedicine and its potential to improve patient care.

source: Pharmabiz

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

One Day Seminar on Challenges in Decentralized Procedure (DCP) Filings in Europe.

Pharmaceutical companies intending to market products in the EU must follow one of three distinct processes in order to obtain the required marketing authorizations - Centralized Procedure, Decentralized Procedure or Mutual Recognition Procedure. Of these, the DCP route, adopted to seek approvals where none currently exists, can be a challenging and complex process.

The AIPS Seminar is designed to assist in DCP Deficiency handling vis-a-vis multiple European Authorities. After providing an overview of the European Filing procedures, the seminar will focus on DCP Filing deficiencies,and study issues relating to their impact on the DCP review, the current trend of deficiencies, ways to address these deficiencies, the turn around time for addressing deficiencies etc.

The seminar is recommended for professionals in Process Teams, Analytical Teams, Purchase (API as well as KSM - Alternate sourcing and their impact on API resulting in variations at the formulators end vis-a-vis latest variation guidance which impacts cost of filing variations and launch dates], RA, Marketing, Quality and Production Planning Teams. Project Management officials, etc.

Venue: AIPS, Mumbai
Date: Saturday, May 8, 2010
For more details : info@aips.ac.inMay 2010

5 Day Workshop on Patent Fundamentals and Practice.

This training programme, designed for executives whose scope of work calls for a broad working knowledge of patents, will provide an insight into the related legal & practical issues. Eminent faculty will take the participants through sessions on Patent Basics, Prior Art Search, Data Mining, Search Strategies, Specification Drafting, Filing and Prosecution of Patent Applications including PCT applications, Opposition Procedures at the Indian Patent Office, Claim Interpretation and Analysis, Freedom to Operate guidelines, the Trade Secrets vis-a-vis Patents debate, etc.

Venue: AIPS, Mumbai
Date: May 14 - May 18, 2010
For more details : info@aips.ac.in

Pharmacovigilance workshop in Chennai

DIA has organized a workshop "Pharmacovigilance and Risk Management" in Chennai on February 20-21, 2010.

Featured Topics
• Risk Management

• National pharmocovigilance programme: Progress, Status and Challenges

• KPO-Pharmacovigilance Model
• Human Resource Development in Pharmacovigilance
• Management of Pharmacovigilance the MNC Way
• Pragmatic Approaches to Pharmacovigilance in Light of CIOMS Pharmacovigilance Working Group Recommendations
• Regulatory Inspections
• Selection, Installation and Attributes of Ideal Pharmacovigilance Software
• Pharmacoepidemiology: Applications and Current Relevance to India

All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.

Venue: Taj Mount Road, Chennai, India

Contact:
DIA (India) Private Limited,
A-303, Wellington Business Park I,
Andheri-Kurla Road, Marol, Andheri (East), Mumbai 400 059 India
Phone: +91-22-6765-3226
Fax: +91-22-28594762

Two-day clinic on “Meeting the Inventor”

The Academy of Intellectual Property Studies (AIPS) will be organizing a two- day clinic on “Meeting the Inventor” on February 12 and 13.

The clinic will be an in-depth analysis of the interaction between the inventor and the IP cell in an organization. In an effort to maximize the IP value of the R&D efforts of the organization, especially that of the patents it files, the patent has to stand in the court of law and also have the best achievable commercial value. To ensure this, the patent manager / attorney and the actual inventor have to work in tandem, such that the groundwork laid is dependable and foolproof. The clinic is devised to develop related expertise, and looks at how the IP cell and the R& D team in an organization should interact such that potential IP is recognized and its full value extracted.

The clinic will adopt a highly interactive methodology .Under the mentorship of experienced professionals, a real-life scenario will be simulated wherein the participants will work on suitable cases.The AIPS clinic will train participants with the support of leading faculty H. Subramaniam of Subramaniam, Natraj & Associates, New Delhi and Dr B N Roy of Lupin Ltd.

For more details e-mail info@aips.ac.in or gita@aips.ac.in

Workshop on 'Impurities in Drug Substances' on Jan 23 in Mumbai

Academy of Intellectual Property Studies (AIPS) is organizing a one-day workshop on Impurities in Drug Substances – US & Europe Perspective – with a special focus on Genotixic Impurities on January 23, 2010 at AIPS Mumbai.

The AIPS workshop on 'Impurities in Drug Substances – US & Europe Perspective' will study the current regulatory environment in which the drug developers operate, with a special focus on genotoxic impurities. Concerns of the small to mid-sized company, possible strategies that could be adopted while dealing with the regulatory authorities, development and validation of analytical methods to manage genotoxic impurities, study of the recent causes of concern vis-à-vis genotoxic impurities etc will be examined in addition to an overview of the existing official Guidelines and protocols, reporting practices etc.

The workshop is recommended for scientists working in R&D, Regulatory Affairs, Quality Control / Quality Assurance, Toxicology, Manufacturing, Compliance, Preclinical Development etc.

Venue: AIPS, Mumbai.
For more details,contact: gita@aips.ac.in or info@aips.ac.in

Staff Development Programme @ Periyar College of Pharmacy

STAFF DEVELOPMENT PROGRAMME "CURRENT TRENDS IN CLINICAL RESEARCH" Sponsored By All India Council For Technical Education New Delhi Organized

Click here to view the photos from this programme.

One Day Workshop on Impurities in Drug Substances

The overall quality of a drug substance or pharmaceutical most often depends on the extent to which the level of impurity in it has been controlled. Unfortunately impurities, suggestive of risks, can rarely be brought down to zero, and efforts can only be made to reduce them to the lowest levels that are reasonably practical. Several international guidelines have been arrived at to aid the drug developers and regulatory agencies to evaluate and control the impurities in drug substances these methods for detecting and controlling the impurities are subject to continuous review and improvement, and the concerned departments need to keep updated by keeping a close watch on the various guidances being issued by the authorities, understanding the rationale and requirements fully.

This workshop will study the current regulatory environment in which the drug developers operate, with a special focus on genotoxic impurities arising in drug substances. Concerns of the small to mid-sized company, possible strategies that could be adopted while dealing with the regulatory authorities, development and validation of analytical methods to manage genotoxic impurities, study of the recent causes of concern vis-a-vis genotoxic impurities etc. will be examined in addition to an overview of the existing official Guidelines and protocols, reporting practices etc.

The workshop is recommended for scientists working in R&D, Regulatory Affairs, Quality Control / Quality Assurance, Toxicology, Manufacturing, Compliance, Preclinical Development etc.

Venue: AIPS, Mumbai

Date: January 23, 2010

For more details: info@aips.ac.in

Advanced GCP workshop - 30 Nov 2009, Hyderabad

Workshop on GCP 2010: FAQs Exploring common GCP Myths and misconceptions
30 November 2009
At Hotel Green Park, Hyderabad
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. 4500/-per participant
(Inclusive of course material, lunch and refreshments)

Who would benefit – This highly interactive workshop is an essential GCP refresher and problem solver for all clinical research professionals striving for GCP compliance amidst multiple priorities. Understand where we commonly misinterpret GCP requirements and add more chaos to the already existing dichotomies. Learn to separate the facts and true expectations of GCP compliance in clinical research in order to become more effective. An absolute must attend for all clinical research professionals in sponsor, CRO, SMO companies, principal investigators and site staff.

About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP Trainer 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, helping identify/audit 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 US FDA. 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.

To register, please send email to:
anupama.ramkumar@ gmail.com; ranjani@pharmantra. com or
Call - Dr Anupama at 98254 13761 or Dr. Ranjani at 99590 72225

Seminar on 'good cleaning validation practices' in Chennai on Oct 12

The Chennai-based Easy Solutions will organize a one-day seminar on 'good cleaning validation practices' for pharmaceutical manufacturing equipment in Mumbai on October 12. This course is intended for process engineers, production staff, quality assurance, validation and other technical management personnel having some familiarity and experience with the basic subject as it applies to research and manufacturing of pharmaceuticals, personal care products, nutritional materials and fine chemicals.

Upon completion of this workshop the participant will be able to understand and apply:

● Principles and calculations of residue limits

● Selection of analytical methods to measure residues

● Selection of sampling methods

● Determining cleaning validation acceptance criteria

● Basics of cleaning validation strategies.

The seminar is led by Destin A. LeBlanc - a specialist in pharmaceutical cleaning validation and has written and lectured internationally on cleaning validation. He brings a unique perspective because of his expertise in effective design of cleaning processes as well as the validation of those processes. He is the author of a recent book "Validated Cleaning Technologies for Pharmaceutical Manufacturing".

For details contact Easy Solutions at sales@cleanroommart.com

5-day course on solid dosage manufacturing in Hyderabad from Aug 24-29

Aveta Lifesciences Private Ltd has announced a five-day course on "Solid dosage manufacturing: A Comprehensive Study of Tablet Manufacturing" specially designed for managers & senior supervisors in Hyderabad from August 24 to 28, 2009.

The five days of intensive training will include topics such as introduction to tablet formulation & powder milling, powder granulation operation, powder blending operation, tablet press operation and aqueous film coating operation.

The course will be conducted by Fred A. Rowley, international expert in solid dosage and hard shell capsule manufacturing. He is a professional lecturer and teacher and has taught all over the world. Rowley has a vast repertoire of courses relating to the solid dosage technologies for tablets, hard shell and soft gelatin capsules. Each year, he dedicates a portion of his time towards helping all those who desire to improve their knowledge of the various solid dosage forms. Rowley believes that world-class technical training should not be the sole prerogative of the big pharma companies with deep pockets. Aveta Lifesciences shares this view and strives to make quality products available at affordable costs.

Workshop on Clinical Trial Protocol Writing at NIPER on August 24th – 28th, 2009

National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad has organized a Workshop on Clinical Trial Protocol Writing on August 24th – 28th, 2009 with the support of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India

A clinical trial protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents. The protocol contains a study plan on which the clinical trial is based.

The main goal of the workshop is to provide advancement in knowledge and skills of persons working or intending to work in clinical research. This workshop will be of special use to professionals and students associated with pharmaceutical & biotechnology industry, academic institutions, regulatory agencies, clinical research organizations and healthcare Industry.

The following sets of personnel are encouraged to apply:

• CRAs & investigators working in the field who are looking for additional training.
• Professionals wanting to change career within the industry/academia to clinical research.
• Professionals willing to get in the field of clinical research.
• Recently employed personnel in academia or industry requiring comprehensive training in clinical research.

The topics proposed for workshop are:

• Basics of medical writing
• Writing SOPs
• Understanding of research designs
• Designing a study protocol
• Clinical Trial protocol writing
• Clinical Research Report writing.

Registration Fees
(Covers workshop material, participation to meetings, food arrangements for the days of symposium)
Industry: Rs. 10,000/- only
Academia: Rs.5,000/= only
Students: Rs.2,500/= only (M. Pharm., MBBS, MD)

Click here for more information

Demystifying Clinical Trials

GVK Biosciences (GVK BIO), Asia’s leading research services organization, recently conducted a media workshop ‘Demystifying Clinical Trials’ at its Clinical Pharmacology Facility in Ameerpet in Hyderabad.

The objective of the Workshop was to take participating journalists through Drug Development, the Clinical Research process (how clinical trials are set up, conducted and completed) and Systems of Human Subject/Volunteer protection. It was primarily aimed at providing healthcare journalists with a good understanding of the drug discovery and development process thus enabling greater appreciation of the context in which clinical trials/bioequivalence studies are conducted. Issues related to human subject protection were the main focus of the Workshop. This was followed by a site visit of the GVK BIO Bioequivalence Facility Tour.

Speaking on the occasion Mr. Manni Kantipudi, President, GVK Biosciences said, “We believe that media plays an important role in highlighting the core issues concerning public and this session was to take them through the processes involved in conducting trials.”Dr. Mukherjee said that, “It is important to ensure that the trials are conducted in a most ethical manner and we at GVK BIO strive to provide the best clinical development services to our clients in India and globally.”

This interactive workshop ‘Demystifying Clinical Trials in India’ was very well received and the level of participation quite encouraging. Dr. Shoibal Mukherjee, Senior Vice President – Clinical Development, GVK BIO and Dr. Sailendra Goswami, Vice President – M&A, Clinical Pharmacology, GVK BIO shared their views on drug development, clinical trials and bioequivalence studies and highlighted the best practices adopted by the leading Contract Research Organizations such as GVK BIO to ensure highest safety ofsubjects/volunteers involved in the processes.

GVK BIO plans to hold such workshops in other areas of life‐sciences too and also have updates on a regular basis for the media.

Workshop on Advance GCP - Theory to practice

Clinical Research Education and Management Academy (CREMA) announced a two day workshop on “Advance GCP – Theory to Practice” by Dr. Arun Bhatt MD (Med) FICP (Ind) MFPM (UK) FICR (UK), President ClinInvent Research Pvt Ltd.

Date : August 7th & 8th, 2009

The two day workshop aims to provide practical application of GCP for important clinical trial processes.

Learning Objectives

• Review and update GCP knowledge

• Recognize the challenges of site selection

• Understand the issues involved in planning of clinical trial

• Analyze ethics committee approval process

• Assess acceptability of informed consent

• Discuss monitoring aspects of protocol compliance

• Comprehend identification and handling of safety issues Who Should AttendThis course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, and Study Coordinators.

Venue: Clinical Research Education and Management Academy

401 - Shree Amba Shanti Chambers

Next to Leela Business Park

Andheri Kurla Road

Andheri EastMumbai - 400 059

Board No : +91 - 22 - 66715491 - 92

Fax No : +91 - 22 - 66715490

For more information please log on to www.cremaindia.org

Or ContactAmit Sethi +91-9987028131amitsethi@cremaindia.org

Refresher course for working pharmacists

Vinayaka Mission College of Pharmacy, Salem will conduct a refresher course for all the registered working pharmacists in Salem districts on July 26. The course is sponsored by Tamil Nadu Pharmacy Council and will be conducted in the college campus.

Dr T Elango, registrar of the TNPC said its president Dr K Chinnasami will deliver a speech on 'the impact of cardiac and diabetic drugs' while inaugurating the refresher programme.Dr P M Balasubrahmaniam, chairman of the Adverse Drug Reaction Committee constituted by the pharmacy council, Dr B Jaikar, principal of the College, Dr S Gopalakrishnan, professor and HoD, Dept of Pharmaceutical Practice, Dr S Sriram, professor and HoD, Dept of Pharmaceutical Chemistry Ramakrishna Institute of Pharmacy Practice, Coimbatore and S Selvaraj, Assistant Director of Drugs Control, Salem zone will speak on this occasion.

Later the first meeting of the Adverse Drugs Reaction committee will be held in the college, said Dr T Elango. The meeting will evaluate and formulate the modus operandi of the ADR Committee. The Principal of the Vinayaka Mission College, Dr B Jaikar is the convener of the ADR Committee. He said certain hospitals in the district have been selected to collect the patients' reactions on newer drugs.

Lecture cum Practice on Patent Specification Drafting and Patent Prior Art Search

The Academy of Intellectual Property Studies (AIPS) has announced two new lecture series.

Lecture Series on Patent Specification Drafting
This course comprises five full day lecture cum practice sessions, and is designed for IP / Patent professionals wanting to improve specification writing and claim drafting skills. Expert faculty will guide the participants through both mechanical and chemical cases, and group and individual exercises will provide hands-on practice. One session is expected to be devoted especially to Pharmaceutical Drafting.

Commencement August 8, 2009
Timings 9.30 am - 5.30 pm .
Dates : August 8, August 22, August 29, September 5 and September 12, 2009 . (Saturdays only)

Lecture cum Practice Sessions on Patent Prior Art Search
The sessions will cover the basics of patent documentation, search tools and techniques, study of the search results and preparation of the search report. Participants will be taught to initiate search proceedings in the most appropriate manner, retrieve relevant documents and thereafter prepare the search reports. The Faculty will be covering both the web based free databases and a few paid sites.
Commencement August 8, 2009.
For details, contact AIPS at info@aips.ac.in

Certificate of participation will be issued for both the courses.

A SEMINAR /WORK SHOP ON “EXPORT OPPORTUNITIES FOR PHARMA AND HERBAL INDUSTRIES “

In order to help the SMEs to venture / improve their exports in Pharma Sector, PHARMEXCIL, is conducting a seminar on “EXPORT OPPORTUNITIES FOR PHARMA AND HERBAL INDUSTRIES “

Date: Friday 17th July, 2009

Time: 9.30 am - 5.00 pm

Venue: The Residency Towers, Press Road Statue, TRIVANDRUM 1

Pharmexcil, DGFT, ECGC, EXIM Bank, SIDBI and SMERA etc will make Presentations. Topics pertaining to Herbal Product Registrations in the regulated and semi regulated markets for Exports are covered. Also the Kerala Drug Regulatory Authorities would participate in the one to one question answer session.

Registration Fee: Rs. 300 per Participant
You may send DD/ Cheque in the name of “Pharmaceuticals Export Promotion Council” payable at Hyderabad before 14th July 2009.

Cash payment at the venue is accepted for the members registering in advance.For registrations, Please contact info@pharmexcil.com,

Mr. G. Vijay Kumar, Consultant Advisor, Pharmexcil, (09849015527)

Mr MP George, Drugs Controller, Kerala (9447010210)

Prof Vimala Devi, President, FIHI (09486366075)

Biotechnology Leadership Camp (BioCamp) at Hyderabad

Novartis India is organising its Biotechnology Leadership Camp (BioCamp) on August 11 and 12, 2009 in Hyderabad to bring in young students from diverse fields and different universities to form a talent pool for pharma and biotech industries.

BioCamp is open to postgraduate students and young researchers in science, pharmacology, medicine, biotechnology, business management (preference to students with a science background) or law (specialization in Intellectual Property Rights) interested in pursuing a career in the pharma and biotech industry.

Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical, biotechnology and business sector as well as increase their team building skills. The top two students from the India BioCamp will represent India at the International BioCamp being held at the Novartis Institute of BioMedical Research, Cambridge, USA from October 27 to 31, 2009, informed a Novartis press release. Last date for receiving applications is July 10, 2009and more information would be available through biocamp.india@novartis.com.

Workshops in Mumbai - Clinical research, SOPs and Inspections

Tools for Compliance – SOPs Guide to defining need, development and maintenance of SOPs
&
Regulatory Inspections : Preparing for and meeting expectations

17 - 18 July 2009 at The Residence Hotel & Convention Centre & Ramada, Powai, 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. 5500/-per workshop
(Inclusive of course material, lunch and refreshments; discounts available for groups and individuals who register for both workshops)

Who would benefit – Clinical research professionals in sponsor, CRO, SMO companies, principal investigators and site staff engaged in activities requiring compliance with regulatory and GCP requirements.

About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP Trainer 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, helping identify/audit 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 US FDA. 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.

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