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.
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