Academy of Intellectual Property Studies is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.
Introduction to Regulatory Affairs
Good Manufacturing Practices, QA and Regulation
ICH
Dossier preparation and CTD Compilation
Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World
Clinical Investigational Studies
Pharma Patents, IPR and Regulation
Electronic Submissions
To register, please e-mail info@aips.ac.in
