IPA/EDQM/WHO Technical Conference 2012
September 28th - 29th, 2012, Mumbai

The 2-day long IPA - EDQM - WHO Technical Conference 2012 was organized by Indian Pharmaceutical Association (IPA), in collaboration with European Directorate of Quality of Medicines (EDQM) & World Health Organization (WHO). This Conference is the 3rd in the series of similar programs organized by Indian Pharmaceutical Association with EDQM in the last 5 years. Having gone through the EU Regulatory specifications in the first edition of this Conference in 2007 & Global GMP & Regulatory Perspectives in 2010, this time around the program was focused on Global Regulatory Compliance challenges of active pharmaceutical ingredients (APIs).

The program began with the inaugural session, with Mr. S. D. Joag - Hon. Gen. Secretary of IPA, Dr. J. A. S. Giri - President of IPA, Dr. Florence Benoit-Guyod - EDQM & Dr. Milan Smid - WHO welcoming the delegates. The keynote address was delivered by Dr. P. Khadgapathi - Director Hetero group & Chairman - Industrial Pharmacy Division of IPA, during which he gave the Indian API manufacturers’ perspective as far as quality assurance of APIs was concerned.

The first session of the program, on ?Regulatory Requirements with relevance for APIs?, chaired by Dr. Venugopal Somani ? Deputy DCGI, had talks by Dr. Florence Benoit-Guyod, where she gave an overview of Europe?s updated approach to assurance of API quality & its implications for the global API manufacturers. This was followed by a presentation by Mr. Ian Thrussel, WHO, on application of Quality by Design concept in production of APIs. The last talk in the session was by Mr. S. M. Mudda, Executive Director, Technical & Operations, Micro Labs Ltd., where he gave an overview of the EU Falsified Medicine Directive, with a special emphasis on Indian concerns on implementation of the directive & it being misused as a protectionist measure by the EU regulators. The post-lunch session of the day had two parallel sessions. The first was on ?GMP compliance in production of APIs?, was moderated by Dr. Nandkumar Chodankar, where Mr. Ian Thrussel, Dr. Florence Benoit-Guyod & Dr. Albinus D?sa, Deputy Director ? US FDA, India Office made detailed presentations on WHO, EDQM & US FDA inspection of API manufacturing sites respectively. The last talk of the session was delivered once again by Mr. Ian Thrussel where he dwelt on international collaboration in API inspection programs, with the ultimate aim of securing global supply chains. The second parallel session on ?Documentation of API Quality as required for Regulatory purposes?, moderated by Dr. B. R. Jagashetty, Drug Controller, Karnataka state, had the first talk by Dr. Vishwanath Malkar, Consultant, on demonstration of quality of APIs. Dr. Maryam Mehmandoust made the next presentation on EU requirements on quality of APIs. This was followed by two short presentations by Dr. Antony Fake, on API documentation from the perspective of WHO prequalification program & typical API issues arising during assessment of finished pharmaceutical products, seeking WHO prequalification.

The second day of the program commenced with a session on ?Update on Pharmacopoeial Developments?, was chaired by Dr. Ajit Dangi ? President & CEO, Danssen Consulting, where Dr. Pascale Poukens-Renwart - EDQM, Dr. Antony Fake & Dr. Vinay Nayak - , Almbic Pharmaceuticals Ltd., gave updates on European, International & Indian Pharmacopoeias respectively. Dr. Nayak further went on to discuss the salient aspects of the initiative for pharmacopoeial harmonization. The last session of the program on ?API certification & prequalification schemes? was moderated by Mr. Devinder Pal - Head, Catalyst Pharma Consulting, where Dr. Pascale Poukens & Dr. Antony Fake gave details about EDQM certification & WHO prequalification programs respectively.

Every session of the program concluded with marathon, interactive panel discussions. During the program two complimentary copies of European Pharmacopoeia 7.0 were handed over to Bombay College of Pharmacy & the lucky draw winner ? Mr. Ramesh Patel, Assistant Manager, Amoli Organics Pvt. Ltd. respectively. The program witnessed a huge turn-out of professionals from the pharma industry.

 
Download Speaker Presentations
1. Ms. Maryam - EU requirements for quality of APIs in Marketing Authorisation Application
1. Dr. Milan Smid - WHO Prequalification of Medicines Programme ? General overview and update
2. Dr. Antony Fake - WHO API prequalification procedure and APIMF procedure ? Practical Details
3. Dr. Pascale Poukens, Renward - How to prepare a new CEP application, Top ten deficiencies during
   assessment of CEP dossiers
4. Dr. Pascale Poukens, Renward - How to prepare a CEP revision application
5. Dr. Florence Benoit, Guyod - How to prepare an EDQM inspection
6a. Dr. Pascale Poukens, Renward - Case Study 1
6b. Dr. Pascale Poukens, Renward - Case Study 2
6c. Dr. Pascale Poukens, Renward - Case Study 3
7. Dr. P. Khadgapathi - Global Challenges in quality assurance of APIs from the perspective of Indian
    manufacturers
8. Dr. Florence Benoit-Guyod - Europe?s new approach to assurance of API quality and its implications for
    manufacturers and producing countries
9. Mr. Ian R. Thrussell - Quality by Design (QbD) and Pharmaceutical Active Ingredient Maufacture
10. Dr. S. M. Mudda -The implementation of the EU Falsified Medicines Directives from the perspective of
    Indian manufacturers and Indian authorities
11. Mr. Ian R. Thrussell - WHO API GMP Inspections
12. Dr. Florence Benoit-Guyod - Inspection of API manufacturers organized by EDQM and the
    increasing international collaboration
13. Dr. Albinus D?Sa - US FDA inspections of API manufacturers in India
14. Mr. Ian R. Thrussell - International Collaboration in the organization of API inspections
15. Dr. Antony Fake - API documentation from the perspective of WHO PQP
16. Dr. Antony Fake - API issues arising during assessment of Finished Pharmaceutical Products
    (Generic Drugs) seeking WHO prequalification
17. Dr. Pascale Poukens - Renwart - European Pharmacopoeia and Pharmacopoeial Discussion Group (PDG)
    update
18. Dr. Antony Fake - International Pharmacopoeia update
19. Dr. Vinay Nayak - Pharmacopoeial harmonization process
20. Dr. Pascale Poukens - Renwart - EDQM certification scheme
21. Dr. Antony Fake - WHO prequalification of APIs
 
Photo Gallery

 
(L-R). Dr. Milan Smid, Dr. P. Khadgapathi Dr. J.A.S. Giri and Dr. Florence Benoit- Guyod during the inaugural session.   Mr. S.D. Joag welcoming the delegates.
     
 
IPA President, Dr. J.A.S. Giri making the introductory remarks. Dr. Milan Smid and Dr. P. Khadgapathi (L-R) look on.   IPA Vice President and Chairman, Industrial Pharmacy Division ? Dr. P. Khadgapathi delivering keynote address.
     
 
Dr. Florence Benoit handing over complimentary copy of European Pharmacopoeia 7.0 to Dr. M.N. Saraf, Principal, Bombay College of Pharmacy. Also seen (L-R) Mr. T.B.Nair, Dr. Pascale Poukens, Mr. S.D. Joag and Mr. S.R. Vaidya.   Dr. Florence Benoit handing over complimentary copy of European Pharmacopoeia 7.0 to the lucky draw winner Mr. Ramesh Patel, Asstant Manger, Amoli Organics Pvt. Ltd. Also seen (L-R) Mr. T.B. Nair, Dr. Pascale Poukens, Dr. Alka Mukne, Mr. S.D. Joag and Mr. S.R.Vaidya.
     
 
Speakers & Members of Organizing Committee. Standing in the back row (L-R) Mr. S.R. Vaidya, Mr. S.M. Mudda, Mr. Ian R. Thrussell, Dr. Milan Smid, Dr. Maryam Mehmandoust, Dr. Pascale Poukens, Dr. Florence Benoit-Guyod, and Dr. Anthony Fake. Standing in the front row (L-R) Dr. Alka Mukne, Dr. B.R. Jagashetty, Dr. Venugopal Somani, Dr. C.Gopalakrishna Murty, Dr. Vishwanath Malkar, Dr. Nandkumar Chodankar and Mr. S.D. Joag.   Speakers & Members of Organizing Committee. Standing in back row (L-R) Dr. Florence Benoit-Guyod, Mr. Ian R. Thrussell, Dr. Pascale Poukens, Mr. Devinder Pal, Dr. Ajit Dangi, Dr. Maryam Mehmandoust, Dr. Antony Fake and Dr. Milan Smid. Standing in front row (L-R) Dr. Alka Mukne, Mr. Subodh Priolkar, Mr. S.R. Vaidya and Mr. S.D. Joag.
     
   
Delegates during the sessions.