The Medical Subcommittee of IDMA is organising a seminar on ‘Schedule Y - The New Look’ on Saturday 27th August 2005 at Mayfair Rooms, Worli, Mumbai.
The seminar is intended to familiarize various aspects of the changes in schedule Y to the medical and regulatory departments of pharmaceutical companies, persons interested in pursuing career in pharmaceuticals, CROs/research institutes, personnel involved with various aspects of drug approval/ clinical trials etc.
Major topics the seminar will cover include changes in Schedule Y and its impact on pharma industry, clearance of drugs and FDC’s - view point of state drug control authorities, regulatory aspects of biotech pharmaceuticals, practical aspects in clinical trials due to the need for GCP, challenges in selection of investigator, monitoring of clinical trials, ethical issues in clinical trials etc.
Senior industry experts and top regulatory officials in the country will lead the sessions. Ashwini Kumar, Drugs Controller General India is also likely to participate in the event.
IDMA sources said emphasis has been on topics that are of vital concern in regulatory procedures related to Schedule Y. These have been identified after discussions with various experts working in medical and regulatory departments of pharmaceutical industries, and also with regulatory consultants.