A workshop on “Drug Regulatory Affairs” with focus on Pharma is being held at Ramanbhai Patel College of Pharmacy on 20th and 21st April-2012.
This workshop will facilitate the understanding of regulatory services in the health care verticals of Pharmaceutical Dosage Form, clinical research organization, bio-similar & biotechnology. It will help to maintain a competitive edge to overcome the regulatory obstacles. This workshop helps to participants to shape and strengthen submission, avoid duplicating past submission mistakes made by others, speed up the approval process and gain a comprehensive overview of regulatory requirements. It will provide the platform for the Professionals of Pharmaceutical Industries and academia to enrich their knowledge and alleviate their research ability in the field of regulatory requirement.
The topics covers under this workshop are:
· Good Manufacturing Practices
· Quality Risk Management
· Overview of SUPAC Guideline
· WHO Guidelines for inspection of Pharmaceutical Manufacturers
· Pharmaceutical Quality System
· Drug Master File (DMF)
· Marketing Authorization & Dossier requirement in Europe
· Overview on ANDA Submission
· Brief Overview of NDA & IND
· Impurities
Speakers are from major pharma companies like Zydus Cadila, Intas Pharmaceuticals, Unimark Remedies, Astron Research Center, Alembic Ltd & Pharma consultant, etc. Please refer to attached brochure for detailed information.
The brochure and registration form are attached here with. Kindly circulate it among your other colleagues, students (PG and Research Scholars) and staff members for their participation.
As there are limited seats available, you can send us an early confirmation by sending us the filled registration form on rpcp.dra@charusat.ac.in
For any information on workshop, email at rpcp.dra@charusat.ac.in
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