The Drug Information Association (DIA) in cooperation with World Health Organization (WHO) and European Directorate for Quality of Medicines and Healthcare (EDQM) is organizing a global conference on 'Quality of Active Pharmaceutical Ingredients' from September 5 to 7 2009 at Hotel Taj Krishna, Hyderabad. A large number of expert speakers from EU, US FDA, WHO and EDQM are expected to participate in the conference.
There will also be three workshops/tutorials which will be held on September 5 on subjects like 'Workshop on CEPs (Certification Procedure in Europe)', 'Workshop on importance and methods for moving from common technical documents (e CTD) and 'Workshop on WHO pre-qualification programme for priority medicines'.
S Srinivasan CEO, MD of Matrix Laboratories and Dr J M Khanna, executive director, Jubilant Organosys will be the keynote speakers at the conference.
This international conference will create the right platform for Indian API Industry in meeting international standards. There will also be an opportunity for the Indian industry to promote the industry through networking, tabletop and banner display.
The major focus of this conference will be on the current regulatory requirements for the quality of API, compliance with GMP standards from global regulatory authorities perspective. The conference will also focus on the current issues of pharmacopoeial monographs, as well as API Certification and WHO Prequalification requirements. Featured topics for the conference will be regulatory requirements with relevance for quality of API compliance of API manufacturers with current GMP standards, current issues and challenges in the development of pharmacopoeial monograph and API certification and WHO prequalification.
At the conclusion of this meeting, participants should be able to describe the regulatory issues of API manufacturing and compliance, explain the current compliance issues of API, discuss the requirements of the API under the prequalification program and outline the procedures for Certification of Suitability (CoS).
Government regulators, regulatory affairs associates from industry, people from chemistry manufacturing and controls, people from analytical development chemistry, people from formulation development and technical services, QA, QC should attend the meeting, DIA spokesman Manoj Trivedi said.