Certificate Course in Drug Regulatory Affairs (DRA)

Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)

4.11 (2499 reviews)

Udemy

platform

English

language

Science

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.

Course Gallery

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Comidoc Review

Our Verdict

The Certificate Course in Drug Regulatory Affairs (DRA) serves as an informative deep dive into drug regulations and USFDA processes, with a knowledgeable instructor. Despite some minor drawbacks, such as accent-related comprehension issues and limited practical applications, the course extensively covers essential aspects of DRA like NDA, ANDA, CTD, DMF, GMP, Clinical Research, and BLA. However, learners from regions outside the US might encounter less relevant content. Ensure you're comfortable with some animation distractions too. By addressing these minor issues and enhancing practical examples, this course could more effectively help students grasp DRA principles.

What We Liked

Comprehensive coverage of Drug Regulatory Affairs (DRA) and USFDA regulations
Covers critical aspects such as NDA, ANDA, CTD, DMF, GMP, Clinical Research, and BLA
Accessible to learners with limited prior knowledge, presenting complex concepts clearly
Highly informative and well-structured course content
Knowledgeable instructor engaged learners throughout the course

Potential Drawbacks

Accent of the instructor can sometimes be challenging to understand
Limited practical applications in favor of theoretical knowledge
Animation distractions during slide transition may affect learner focus
Some irrelevant information for non-US learners, such as those based in South Africa
Occasional background music complicates concentration on the lecture