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Professional Certificate Course in Drug Regulatory Affairs
Rating: 4.3 out of 5(86 ratings)
222 students

Professional Certificate Course in Drug Regulatory Affairs

DRA, CTD, eCTD, INDA, NDA, ANDA, DMF, ICH, Orange book, 505 (b)(2) application, MAA, ASMF, Hatch-Waxman act, Dossier
Created byPV Drug Safety Academy
Last updated 5/2026
English

What you'll learn

  • Introduction, Definition and Objectives of DRA
  • Drug Life-Cycle, Origin and Evolution of DRA
  • Types of Applications - IND, NDA and ANDA
  • Generic Drug Product and DMF
  • 505 (b)(2) application
  • ICH guidelines for preparation of Registration Dossiers
  • Orange Book and Hatch-Waxman act
  • 180 days exclusivity, Dossier and CMC in Regulatory affairs
  • Important Regulatory Bodies - CDSCO, USFDA, EMEA, MHRA, TGA, ICH
  • CTD and eCTD; Quality Assurance and Quality Control

Course content

6 sections • 29 lectures • 2h 17m total length

  • Topics to be discussed4:56
  • Drug Life-Cycle7:21
  • Types of Drugs5:38
  • Origin and Evolution of DRA3:04
  • Role of Regulatory Affairs Consultant3:49
  • Required Education and Skills2:18

    Earn bachelor’s or master’s degree in pharmacy, life sciences, or medicine to qualify as a regulatory affairs specialist or consultant, applying regulatory knowledge, analytical skills, and clear communication with stakeholders.

  • Role and Scope of DRA6:11
  • Quiz

Requirements

  • Basic level of English
  • Good quality of Internet connection
  • Desktop, Laptop or Smartphone

Description

Professional Certificate Course in Drug Regulatory Affairs [DRA]

Are you looking to build a successful career in the pharmaceutical industry? Do you want to master the regulations governing drug approval, safety, and compliance? Enroll in the Professional Certificate Course in Drug Regulatory Affairs (DRA) and gain comprehensive knowledge of the regulatory processes required for bringing pharmaceutical products to market.

This course covers critical topics like regulatory requirements for drug development, clinical trials, marketing approvals, and post-marketing surveillance. You'll learn about key regulatory bodies such as the FDA, EMA, and WHO, and their role in ensuring drug safety and efficacy. Ideal for professionals in the pharmaceutical industry, healthcare sector, or students aspiring to enter the field of regulatory affairs, this course equips you with the skills and certification needed to advance your career.

What you'll learn:

  • Understanding of global regulatory frameworks for drug approval

  • Insights into drug development, clinical trials, and post-approval regulations

  • Knowledge of FDA, EMA, and other international regulatory authorities

  • Strategies for ensuring compliance and handling regulatory submissions

  • Best practices in risk management, labeling, and pharmacovigilance

Who should enroll:

  • Pharmaceutical professionals

  • Regulatory affairs specialists

  • Healthcare professionals

  • Pharmacy students or graduates

  • Anyone looking to enhance their knowledge of drug regulatory affairs

Boost your career potential with in-demand regulatory knowledge and certification in Drug Regulatory Affairs. Enroll today!

Who this course is for:

  • Graduate or postgraduate degree in Pharmacy (e.g. B Pharm, M Pharm, M S Pharm, Pharm D)
  • Graduate or postgraduate degree in Medicine (MBBS, MD, BAMS, BUMS, BHMS)
  • Graduate or postgraduate degree in Life Sciences (BSc, MSc, PhD)

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