Academy of Intellectual Properties (AIPS), Mumbai is organizing a 5-day workshop on International Drug Regulatory Affairs on April 17-21, 2006.
According to officials, this course is designed to provide an insight into the regulatory environment in advanced markets and will provide in depth training in-How individual countries interact: US & Europe; How regulations effect product development strategies; The ability to write DMF's in the new format; Keeping the DMF upto date; Deciding Pricing issues - Coordinated filing vs. Individual filing; Necessary information for effective submissions; Strategies for streamlining the registration application process for faster approval; The advantages and disadvantages for various registration procedures; How to handle inspections and compliance etc.
Faculty includes Dr. Abhay Muthal - deputy general manager - Regulatory Affairs - Sun Pharmaceutical Industries Ltd., G. Srinivas - Drug Regulatory Affairs - Research Centre - Aurobindo Pharma Ltd., Madhusudan Rao - General Manager - Global Regulatory Affairs & Complaince - Dr. Reddy's Laboratories, Zoher Sinhorwala - Manager - Regulatory Affairs - Glenmark Pharmaceuticals etc.
For further details
info@aips.ac.in
Ph: (22) 2650 9035 / 5622 1097