Certificate Course in Drug Regulatory Affairs (DRA)
Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)
4.11 (2390 reviews)
9,731
students
3 hours
content
Mar 2025
last update
$69.99
regular price
What you will learn
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.
Screenshots
Related Topics
4117130
udemy ID
6/11/2021
course created date
7/12/2021
course indexed date
Bot
course submited by