Regulatory AffairsSahaswi Group of Institutions
- Basic understanding and terminologies related to Dug Regulatory Affairs (DRA).
- Why Regulatory Affairs (RA) professional is required in Pharma Industry and essential qualities of RA professionals.
- Understand the role of a Regulatory Affairs Professional in Pharmaceutical industry, Types of companies hiring RA professionals, and DRA objectives.
- Navigation through historical background of US Drug Law and Regulations, and The USFDA regulations for Research and Development (R&D) of Pharmaceuticals.
- Major Agencies for drug regulations In USA and other Countries (Along with downloadable website hyperlinked PDFs).
- Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA, Hatch-Waxman Act, etc.
- Orange book, Therapeutic Equivalence Evaluations Codes.
- Drug Master File- Related Terms, benefits, Annual update, Database status, Requirements, Process, Types, etc.)
- Common Technical Document (CTD), Modules, ACTD Vs ICH-CTD.
- Electronic Common Technical Document (eCTD), eCTD technical components, eCTD submissions, Paper CTD Vs eCTD , Various eCTD softwares.
- Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP).
- Clinical Research
- Biologics License Application (BLA) and Purple Book.
- Discover how to navigate important websites including ICH Guidelines to find more relevant information.
- Professional reputation building and career success enhancement through proper understanding of Drug Regulatory Affairs and related concepts.
Who this course is for:
- This course is for employees of the Pharmaceutical Industry, Pharma entrepreneurs, and Pharma Consultants dealing with Pharmaceuticals and related activities.
- Graduates, Postgraduates, Ph.D. Students (Pharmacy, PharmD, Science, Medical).
- Anyone who is eligible and wants to make a career in Drug Regulatory Affairs.