IPA/EDQM/IPC Technical Conference 2010 January 28th – 29th, 2010, Mumbai

The 2-day long IPA – EDQM – IPC Technical Conference 2010 was organized by Indian Pharmaceutical Association, in collaboration with European Directorate of Quality of Medicines (EDQM) & Indian Pharmacopoeia Commission (IPC). This Conference is the 2nd in the series of similar programs organized by Indian Pharmaceutical Association with EDQM in the last 3 years. Having gone through the EU Regulatory specifications in the first edition of this Conference in 2007, this time around the focus was on the Global GMP & Regulatory Perspectives.

The program began with the inaugural session, with Mr. S. D. Joag, Hon. Gen. Secretary of IPA, Mr. Subodh Priolkar, Immediate Past President of IPA, Dr. Nitya Anand, Chairman, Indian Pharmacopoeia Commission & Dr. Vinay Nayak, Conference Chair welcoming the delegates. During the function, six professionals from the various streams of pharma were felicitated for the commendable work put in by them - Dr. Venugopal Somani, Deputy DCGI for Regulatory Sciences; Dr. Pratibha Pilgaonkar, Founder Director & CEO, Rubicon Research for Research & Development; Dr. Premanth Shenoy, Head, Regulatory Affairs, Astra Zeneca Ltd., for Quality Assurance; Ms. Aditi Kare Panandikar, Director – Business Development & HRD of Indoco Remedies Limited, for Young Entrepreneur; Mr. Satyawan Hatte, General Manager, Analytical Research, Macleods Pharmaceuticals Ltd., for Contribution for Pharmacopoeial Development & Ms. Anita Desai, Head, Analytical Development of Cipla Ltd., for Analytical Research. On this occasion, the award instituted by Indian Foundation for Pharmaceutical Reference Standard Substances (IFPRESS) in the memory of former DCGI, Late Dr. M. Venkateswarlu was also given. The award was received by Mr. Zoher Sihorwala, Head Regulatory Affairs, Dr. Reddy’s Lab, on behalf of the company.

The keynote address was delivered by Dr. Albinus D’sa, US FDA Country Deputy Director for India. He discussed some of the recent global initiatives from USFDA & some of their India activities. The first session of the program, on “Monograph Development & Recent Advances in Pharmaceutical Sciences”, had talks by Dr. Claude Coune, Head of the Publications & Multimedia Department of EDQM, where he gave an overview of the latest EU Pharmaceutical legislations & also discussed some of the general concepts in European Pharmacopoeia. This was followed by a presentation by Mr. Stefan Almeling, Deputy Head of the Laboratory Department at EDQM on how to use general monographs & specifications related to impurities. The last talk in the session was by Dr. Manjunath Bhanu, Vice President, API Research, Watson Pharma Ltd., where he discussed impurities characterization & control, with many case studies. The second session of the day was on “Reference standards & impurities”, where Dr. Antony Gomes, Head, Quality Management of Shasun, delivered the first talk. Dr. Gomes gave a detailed presentation on characterization & use of reference standards. Mr. Stefan Almeling was the second speaker here, where he gave an overview of the policy and process used to establish and distribute reference standards. The third session on “Smart Supply Chain Management” had the first talk by Dr. Ken Williams, International Sales Director and Applications Specialist within the Spectroscopy Division of Renishaw, on nondestructive methods for qualifying raw materials and APIs. This was followed by two short presentations on ITMS & rapid microbiological techniques for contamination control by Mr. Vilas Bendre, Product Specialist (Pharma & Life Science), Labindia Instruments Pvt. Ltd. & Ms. Manjiri Chunekar is the Managing Director, Don Whitley Scientific Equipments Pvt. Ltd. respectively. The last session of the day on “Harmonization of Pharmacopoeias” had sessions by Dr. C;laude Coune & Dr. Raman Singh, Principal Scientific Officer & Head, R&D of Indian Pharmacopoeia Commission, each of them discussing the latest in Eropean Pharmacopoeia & Indian Pharmacopoeia 2010 respectively.

The second day of the program commenced with a session on “GMP Inspections” where Dr. Andrew McMath, Scientific Officer of Certification of substances Division at EDQM, delivered the very first lecture on the latest in EDQM inspections. This was followed by a brilliant presentation on GMP challenges to global pharma companies by Dr. Muralidhara Gavini, Senior Assistant Country Director, USFDA Mumbai Office. Dr. Venugopal Somani delivered the last talk in this session on the WHO perspective of inspections.The session 6 of the program was on “Certification Procedures” where Dr. Nandakumar Chodankar, President, Exmore, discussed the e-CTD requirements & specifications. This was followed by presentations by Dr. Andrew McMath & Ms. Nathalie Vicente, Scientific Officer for the Certification Division at EDQM, on certification procedures & how to prepare new applications respectively. The penultimate session of the program had talks by Dr. Clude Counce & Dr. Darshan Bhatt, Director of Drug Safety, Vanthys Pharmaceutical Development (P) Ltd., giving the global & Indian perspective of pharmacovigilance respectively. The last presentation of the program was made by Ms. Caroline Larsen Le Tarnec, Head of the Public Relations & Documentation Division at EDQM, on the latest on offer as far as EDQM Publications & Services was concerned.

The program concluded with a marathon, interactive panel discussion. Conference Chair, Dr. Vinay Nayak moderated the question – answer session. The program witnessed a huge turn-out of professionals from the pharma industry.

 
Download Speaker Presentations
1. Albinus D'sa - overview of FDA
2. Andrew McMath - Certification procedure
3. Andrew McMath - EDQM Inspections
4. Antony Gomes - reference standards
5. Caroiline Larsen - EDQM Publications
6. Claude Coune - EU Legislations
7. Claude Coune - General concepts in European PHARMACOPOEIA
8. Claude Coune - Harmonisation
9. Claude Coune - specific monographs
10. Claude Coune -pharmacovigilance
11. Manjunath Bhanu - Impurities Characterization
12. Muralidhara Gavini - GMP Challenges to global pharma companies
13. Nandkumar Chodankar-CTD norms for INDs, DMFs & CTA- Print copy
14. Nathalie Vicente - How to prepare New Application
15. Raman Singh - what's new in IP
16. Stefan Almaling - General Monograph
17. Stefan Almaling - Reference Standards
18. Subodh Priolkar EDQM F
19. Vilas Bendre - Kaye Validator ITMS
 
Photo Gallery

 
Mr. Subodh Priolkar welcoming the delegates at the inauguration session. Also seen (L-R) Dr. Albinus D’Sa, Dr. Nitya Anand, Dr. Vinay Nayak, Dr. Cloude Coune, Mr. S. D. Joag.   Dr. Albinus D’Sa delivering the key note address.
     
 
Dr. Cloude Coune making his presentation   Dr. Ken Williams speaking at the conference
     
 
Ms. Manjiri Chunekar delivering her talk.   Dr. Raman Singh making his presentation.
     
 
Dr. Venugopal Somani receiving memento from Mr. Devinder Pal.   Speakers during the Panel Discussion.
     
 
Speakers and Organizing Team: Sitting (L-R) Dr. Alka Mukne, Ms. Nathalie Vicente, Ms. Caroline Larsen Le Tarmec, Dr. Darshan Bhatt, Dr. Albinus D’Sa, Mr. Kaushik Desai, Mr. Andrew McMath. Standing (L-R) Mr. S. R. Vaidya, Dr. Cloude Coune, Mr. S. D. Joag, Dr. Vinay Nayak, Dr. Nandkumar Chodankar, Mr. Muralidhara Gavini, Mr. Stefan Almeling, Dr. Manjunath Bhanu.   Delegates of the conference