TypeOnline Course
(1 ratings)
Price$490 / Rs. 27500
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Course Title: KPE’s Certificate Program in European Drug Regulatory Affairs

Course Objective: The objective of this course is to impart knowledge and practical understanding about the Drug Regulatory Affairs and approval process in Europe.

This online course utilizes interactive learning tools to guide each participant through to understand of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment, want to understand the basics of EU regulatory affairs
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on European regulatory affairs
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers


1. Orientation to practical understanding European Drug Regulatory process.

2. Simulation to real life Strategic planning in European market

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Month

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

Section 1EU Regulation
Lecture 1Introduction to EU Regulation
Lecture 2Orientation to European Countries and National Regulatory Bodies
Lecture 3EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 4Overview of EU Regulation 
Lecture 5EMA and EMA Authorisation Process
Lecture 6EU MA Application Types and Strategic Planning
Lecture 7EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 8EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 9Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 10Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 11EU Orphan Medicinal Products Regulation
Lecture 12Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 13Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 14Pre-authorisation GMP Inspection
Lecture 15Summary of Product Characteristics 
Lecture 16Compassionate Use
Lecture 17MHRA - UK Regulation 
Lecture 18The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 19EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 20EU Prime Designation
Lecture 21Accelerated assessment by EMEA
Lecture 22EU Adaptive Pathway
Lecture 23European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 24SPOR  - Concept of Master Data Management  
Section 2Clinical Trials
Lecture 25Clinical Trials Terminologies 
Lecture 26Clinical Trial Protocol Writing
Lecture 27Ethics in Clinical Research
Lecture 28Clinical Data Publications
Lecture 29Clinical Trial Failure
Lecture 30Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Drug Dossier Preparation and Submission
Lecture 31Detailed understanding of Drug Dossier
Lecture 32Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 33CMC Dossier & Compliance Management
Lecture 34Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 35Black Box Warning
Lecture 36Importance of effective dossier management
Lecture 37Certificate of Analysis
Lecture 38Discussion on 85 common deficiency in CTD submission dossier
Lecture 39Key Consideration for Drug Master File Preparation and Submission 
Lecture 40Practical Understanding on Drug Master File Preparation and Submission
Lecture 41Site Master File - Detailed Understanding 
Lecture 42DMF Completeness Assessment
Lecture 43Drug Master File - Global Perspective [Across Different Regions]
Section 4Pharmacovigilance Program
Lecture 44ADR Monitoring
Lecture 45Why Pharmacovigilance Process
Lecture 46PSUR : Detailed Understanding
Lecture 47Risk Management
Lecture 48PV Program Implementation in EU
Section 5Additional Learning Resoruces
Lecture 49United Kingdom’s withdrawal from the European Union ('Brexit')
Lecture 50Comparison of Requirement of Various Regulatory Bodies
Lecture 51Comparison of Dossier Requirements of Europe and US
Section 6Final Examination