Saturday, March 12, 2011
Seminar on European patent prosecution on April 15
Seminar on medical devices in Gujarat on March 18, 19
The Gujarat Food & Drugs Control Administration, (FDCA) will be co-ordinating with the DCGI and WHO to hold this event. This is the first time that the such a training seminar for medical device industry is being organised by the DCGI in the state.
Thursday, December 30, 2010
One day Seminar on PATENT STRATEGIES FOR PROTECTING INVENTIONS IN U.S., EUROPE & INDIA
Saturday, December 18, 2010
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
Wednesday, December 1, 2010
One day Seminar on Bioequivalence
e-mail : info@aips.ac.in
Thursday, June 17, 2010
One Day Seminar on How the Indian Patent Office Decided in 2009
- Brief survey on the adjudicatory functions of the Patent Office with specific focus on section 15 and section 25 orders.
- Survey of all the cases decided by the Patent Office in 2009
- Analysing general trends on how the patent office decides in particular situations involving:
* Request for examination of applications
* Refusal of applications
* Divisional applications
* Abandonment of applications
* Pre-grant opposition of the application
Venue: Academy of Intellectual Property Studies, Mumbai'
One Day Seminar on Pre Grant Opposition
The Patent Office offers a level-playing field for challenging patents before their grant. This mechanism of a Pre-grant Opposition is a legal and cost-effective option, allowing companies to avoid expensive and time consuming infringement suits being brought against them. It also provides a good way to expand business opportunities, and companies have used pre-grant opposition to effectively challenge some of the biggest drugs in history such as Glivec, Forteo, Cialis, Diovan, Iressa, Viread, Caduet, Prezista, Nexium, Hepsera, Tamiflu, etc. The Seminar will study pre-grant opposition as an option, and the Agenda for the day includes:
- General introduction on pre-grant opposition
- The mechanics of drafting, filing and contesting a pre-grant opposition
- Pre-grant opposition and the aftermath: What to do when the matter goes beyond the Patent Office
- Survey of pre-grant opposition cases decided by the Patent Office since 2005 to 2010
- Specific case studies to study the trends in pre-grant opposition
Venue: Academy of Intellectual Property Studies, Mumbai
Saturday, April 24, 2010
One Day Seminar on Challenges in Decentralized Procedure (DCP) Filings in Europe.
Venue: AIPS, Mumbai
Date: Saturday, May 8, 2010
For more details : info@aips.ac.inMay 2010
Thursday, February 4, 2010
National Seminar on Formulation Strategies for Ayurveda, Unani & Siddha Medicinal Products
Only 70 registrations on “First come first served Basis"
Registration Fees:
Rs. 1000/ for Corporate
Rs. 500/ for Academia
Rs. 250/ for Students
Contact:
Mr.Ashish Kshatriya,
Research Scholar,
Department of Pharmacology,
Bombay College of Pharmacy,
Kalina,
Mumbai – 400098
Contact No. +919769619707
E-mail ID: ashishbcp@gmail.com
mnsarafstudents@gmail.com
Sunday, December 27, 2009
Staff Development Programme @ Periyar College of Pharmacy
Click here to view the photos from this programme.
Wednesday, December 23, 2009
2nd International Symposium on Drug Metabolism and Pharmacokinetics (DMPK)
The main goals of the Symposium are to: 1) provide a better understanding of the role that drug metabolism, drug transporters, pharmacokinetics, and pharmacodynamics play in the drug discovery/development process; 2) evaluate new and current techniques and models associated with drug metabolism and drug transporters, as well as development of pharmacokinetic-pharmacodynamic models; 3) gain insights into the issues encountered during the drug discovery process and the interface between discovery and clinical development; and 4) identify processes for reducing the attrition of drug candidates through a better understanding of metabolism and in vitro and in vivo correlations.
This is primarily a lecture-based symposium intended for students and scientists from industry, academia, health-based government organizations, and healthcare professionals with a background in chemistry, biology, or the pharmaceutical sciences, with some experience in the principles and techniques of drug metabolism and pharmacokinetics. The symposium is also intended for experienced researchers in these areas who wish to broaden or supplement their area of expertise, as well as contribute to the discussion topics. Experts from India and abroad in drug metabolism and pharmacokinetics will give presentations and lead discussions at the Symposium.
INVITED SPEAKERS
Dr. Dhiren Thakker, Universtity of North Carolina, USA
SCIENTIFIC PRESENTATION
The oral presentations will be through invited lectures.
For poster presentations, a poster board will be provided to interested participants. The size of the poster board is 48 (height) x 32 (width) inches.
A one page abstract (A4 size) containing title (Arial bold 11 font), address (Roman Times 11 font), followed by the text of the abstract (Roman Times 11 font) is to be sent. A soft copy needs to be submitted via e-mail: dmpk2010@niper.ac.in. LCD projector will be provided for lecture presentations.
NUMBER OF DELEGATES (MAX)
Students : 50Teachers / scientists : 30
BOARDING AND LODGING
Accommodation will be provided on NIPER Campus at nominal charges (per person) for three days as follows. Students in hostel : Rs. 300.00 Others in guest house : Rs. 750.00
If you wish to make your own arrangements, nearest hotels are Sarao Hotel (Ph. 0172-2215885) and Majestic Hotel (Ph. 0172-2232777)
REGISTRATION FEES
(includes scientific matter, food arrangements)
Students : Rs. 2000/-Faculty / scientists : Rs. 3000/-Industry personnel : Rs. 10,000/-
IMPORTANT DATES
Receipt of Abstract : 1st Feb. 2010
Sunday, August 23, 2009
Seminar on 'good cleaning validation practices' in Chennai on Oct 12
Upon completion of this workshop the participant will be able to understand and apply:
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
Friday, July 24, 2009
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.
Wednesday, July 22, 2009
Lecture cum Practice on Patent Specification Drafting and Patent Prior Art Search
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.
Friday, July 3, 2009
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)
Thursday, July 2, 2009
Free Seminar on 'Careers in Clinical Research Industry'
Free Seminar on Careers in Clinical Research Industry
Date : Saturday the 4th July 2009
Time: 10. 00 AM to 12.30PM
Venue: Rajam Hall, MIT Campus (Chromepet)
Contact: Mr. K Srinivasan, Cell: 9677054411
It is co-sponsored by AU-KBC Research Centre of the University and Apollo Hospitals Education and Research Foundation, Chennai.Sources from the University said the seminar is aimed at acquainting graduates and postgraduates of science, engineering and medicine about the emerging clinical research scenario in the country as well as highlighting the career opportunities that this area offers to them. It will outline the training and the skills that are necessary to get absorbed in this industry.
The seminar will provide an opportunity for the participants to listen to various aspects of this subject from leading experts and practitioners. It would also provide details of the full time and part time training programmes being conducted at the University centre.
Dr Vasantha Muthuswamy, former deputy director general, ICMR, New Delhi, Dr VTS Sriram, medical director & academic coordinator, AU-KBC Research Centre, Jayanthi Swaminathan, general manager, AHERF, Chennai, Dr G Ramesh Kumar, academic coordinator, AU-KBC Research Centre are among the speakers participating in the seminar.
Those are interested to participate in this Free Seminar may register here.
Monday, June 8, 2009
Meeting Global Market Challenges- An interactive session with Exporters
This interaction would be mainly focussing on
Ø Export potential of Indian Pharmaceuticals in global market place
Ø Regulatory issues and product registrations
Ø Export Credit
Ø Pre-shipment Inspection related issues.
In short the interaction will focus on tools to cope with current issues and problems confronting pharma companies, especially SMEs and will give them a forum to present their valuable feedback and views.
Members of PHARMEXCIL can participate in this Seminar and take the advantage of direct interaction with the experts who have been invited to speak on important topics of concern.
The registration fee is Rs500/- and can be paid through DD/at par Cheque in favour of Pharmaceuticals Export Promotion Council, payable at Hyderabad.
Here is the Registration Form and Tentative Programme schedule.
Filled in Registration forms are to be sent to rodelhi@pharmexcil.com by e-mail or Fax it to-011-41536658.
Tuesday, June 2, 2009
DIA - TN Chapter opening
The membership fee is Rs 800 to students, Rs 1200 for Academia , Rs 1600 for CRO, Industry ,others Please do send your staff and students and make the event a meaningful and interesting learning session.
Phase 1 Trials in India - The way forward ( Clinical,Ethical and Regulatory Issues) - Tuesday, 9th June 2009Inauguration - 10 min - 0900-0910
Session 1 - 0910- 1010 hrs
1. Overview of Phase 1 Clinical Trials - Dr Nadig( Crema) - 30min
2. Challenges in Phase 1 Trials- Dr Nadig ( Crema)- 20 min Q& A- 10 min
Session 2. - 10 10- 11 10 hrs
1.Clincal Trials& their Ethical Issues- 30min Dr Vasantha Muthuswamy ( former DDG - ICMR)2.Special Concerns in Phase 1 Clinical Trials - 20 min Dr Vasantha Muthuswamy
Q& A- 10min
TEA BREAK - 10 min
Session 3 - 1120- 1220 hrs
1. Regulatory Stand point of Phase 1 Trials in India.Dr Venkateswarlu ( Former DCGI)
2. Challenges in Global scenario vis-a-vis India Where are we and the way forward -Dr Venkateswarlu
DISCUSSION- 30 min 1220 - 1250
Concluding Remarks/PROFILE OF DIA - Dr Nandkumar Chodankar 1250- 1300
Time is not yet fixed - Depends on the auditorium availability 0900- 1300 hrs / or 1300- 17.00 hrs
Probable Venue would be Madras Diabetic Research Foundation.- Conran Smith Rd - in Golpalapuram near CM's house . Venue would be confirmed before June 5th which is the last date to send applications by all interested participants.
Participants who are interested to attend has to enroll for membership in DIA (Drug Information Association) . The application form can be found at http://ifile.%20it/k2xuv5b
Please do contact me if you need any further details
(1) Dr Annabelle Rajaseharan (Professor)9444066519 ; 984063661623751232(Res) after 5 pm (2) Dr Arun (PG student), Stanley Medical College, Chennai9841012335
(3) Dr Sreekanth Gattu (PG Student), SRMC, Chennai9940061168
Tuesday, May 19, 2009
Patent Awareness Seminar
Pharmexcil has so far serviced to about 30 small and big pharma exporters by providing information on Patent status of various drugs and formulations in different countries. The objectives of the council are to educate/help Pharma companies particularly SMEs category, to be aware and utilize the benefits of IPR regime and to ensure hassle (IPR issues) free shipment of their goods to various destinations globally.
In continuation of series of awareness programmes, Pharmexcil is organizing a Programme on 26th May 2009 at Chandigarh, where eminent speakers in the Pharma Patents field viz., Dr. Gopakumar G Nair, Advisor, Pharmexcil, Mr. Feroz Ali, Advocate, Chennai, Miss. Andreya Fernandes, Gopakumar Nair Associates would be making presentations on the Indian and International Patent Scenario in Pharmaceutical sector.
Members can register their names immediately through email at
patents@pharmexcil.com
info@pharmexcil.com
before 22nd May 2009.
For More information please contact:
Patents Analyst, Pharmexcil, 040-23735462/66