Speaker Presentations
The 2-day long IPA EDQM IDMA Convention 2007 was organized by Indian Pharmaceutical Association (IPA), in collaboration with European Directorate of Quality of Medicines (EDQM), from November 28th 29th in Mumbai. The theme of the Convention was Regulatory Gateway to EU Markets : EDQM. The Convention provided a common platform to visiting officials from EDQM, senior members from the Indian Pharmacopoeia Commission & the top brass from the regulatory & QA sectors of the Indian pharma industry, to deliberate on some of the burning issues plaguing the regulatory submissions, approvals & inspection procedures. The Convention also looked at exploring opportunities for joint exercises between the European & Indian regulatory authorities. The programme of the conference was geared to address the concerns of the Indian industry with regards to complying with the EU regulatory specifications & had sessions focused on providing the latest updates on the recent developments in EDQM & Indian Pharmacopoeia, current approval, inspection & certification procedures & monograph development & evaluation processes.The programme began with the welcome address by IPA Hon. Gen. Secretary, Mr. S. D. Joag. In his introductory remarks, Mr. Joag said that this was the first time IPA was organizing this Symposium with EDQM & hoped to have a long standing relationship with them. Speaking on the occasion, Chief Guest, Dr. Parthasaradhy, emphasized on the need for such events. IPA EDQM IDMA awards to felicitate the commendable work done by professionals from research, analytical & regulatory sectors of the pharma industry, were also distributed on this occasion. Dr. Claude Coune, Head of the Publications and Multimedia Department of EDQM bagged the Eminent International Scientist Award 2007. Ms. Gina Malhotra, Head, R & D, Cipla Ltd., was awarded the Eminent Researcher Award 2007. The Pharmaceutical Technologist Award 2007 was given to Mr. Shyam Khante, Head of Global Manufacturing, Dabur. Dr. Raman Singh, Senior Scientific Officer and Head of Research and Development Division, CIPL, received the Excellence in IP development award 2007, whereas Dr. G. Jyothi, Associate Vice President, Matrix Laboratories Ltd. received the Outstanding pharmaceutical analyst award 2007. The recipient of the Quality Management award 2007 was Dr. Pramod Dalvi, Head of Corporate Quality Operations Indian Operation, Watson Pharma.
As a goodwill gesture, EDQM presented IPA with 3 complimentary copies of the 6th Edition of European Pharmacopoeia. The first copy was handed over to Glenmark Pharmaceuticals Ltd., for sending in maximum registrants to this Convention. The winner of the second copy was decided by lucky draw & was gifted to Mr. Ashok Chaudhary from Emcure Pharmaceuticals. The third copy was donated by IPA to Bombay College of Pharmacy for its library.
The technical sessions had lectures on the recent developments at EDQM & Indian Pharmacopoeia Commission (IPC) by Dr. Claude Coune (view complete presentation) & Dr. G.N.Singh, Director, Central Indian Pharmacopoeia Laboratory (CIPL) (view complete presentation) respectively. Dr. Claude Coune (view complete presentation) & consultant, Mr. R.S.Iyer (view complete presentation) also discussed the procedural steps involved in monograph development at the EDQM & IP respectively. Dr. Andrea Lodi, Deputy Head of Laboratory Department, EDQM, discussed the European Pharmacopoeia policy on impurities & their profiling & setting their standards for APIs & finished dosage forms (view complete presentation) whereas Dr. Saranjit Singh, Professor, NIPER, gave the IP perspective about the same (view complete presentation). Dr. Andrea Lodi also elaborated on the reference standards development & certification programme at the EDQM (view complete presentation). Dr. Anthony Gomes, Director, Dr. Reddys Laboratory, gave an insight into the critical issues pertaining to reference standards development & availability in the Indian scenario (view complete presentation).
Day 2 of the programme began with a session on COS/CEP current regulatory processes, submissions, approval & revision processes at the EDQM, by Ms. Helene Bruguera, Deputy Head of Substances Division, EDQM (view complete presentation). Ms. Corinne Pouget, Head, of Substances Division, EDQM, discussed at length, the inspection & certification systems & procedures followed at the EDQM (view complete presentation). Mr. Babu K.S., Senior General Manager, Corporate Regulatory Affairs, Watson Pharma introduced the delegates to the specifications of Q8A & Q9A (view complete presentation). Dr. Claude Coune also informed the delegates about the new features of 6th Edition of European Pharmacopoeia (view complete presentation). Ms. Caroline Larsen Le Tarnec, Head, Public Relations & Documentation Division, EDQM, discussed the important features of the new EDQM website, & how filing online submissions now was so much simpler (view complete presentation). Dr. G.N.Singh apprised the delegates about the new inclusions & deletions in IP 2007 (view complete presentation).
All the sessions were followed by interactive question answer sessions.
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