TypeOnline Course
(1 ratings)
Price$330 / Rs. 16500
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Course Fees


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
  • 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.

Rs. 16,500/- Indian Rupees (Payment From India)

330 USD (Payment from outside India)

This course is divided into following modules

SL Topic Test Learning Duration
1 Introduction to European Drug Regulatory Affairs 1 0.45 HR
2 Orientation to National Regulatory Bodies of European Countries NA 2.00 HR
3 Overview of EU Regulation 1 1.00 HR
4 EMEA Procedures 1 2.00 HR
5 Summary of Product Characteristics 1 1.00 HR
6 Compassionate Use 1 1.00 HR
7 MHRA – UK Regulation 1 1.00 HR
8 Key Understanding of Clinical Trials Terminologies 1 4.00 HR
9 CTD 1 1.00 HR
10 ECTD 1 1.00 HR
11 Dossier Preparation Training 1 2.00 HR
12 Stability Study – Fundamentals 5 8.00 HR
13 EU Orphan Medicinal Products Regulation 1 1.00 HR
14 PV Program : ADR 4 4.00 HR
15 Why Pharmacovigilance Process 1 1.00 HR
16 Why Pharmacovigilance Process 1 1.00 HR
17 PV: Risk Management 1 1.00 HR
18 How regulatory body adopt PV Program in EU? 1 1.00 HR
19 EU Paediatric Regulation 1 1.00 HR
20 MAA 1 1.00 HR

Section 1Introduction to EU Regulation
Section 2Orientation to European Countries and National Regulatory Bodies
Section 3Overview of EU Regulation
Section 4EMEA Procedures
Section 5SmPC
Section 6Compassionate Use
Section 7MHRA - UK Regulation
Section 8Clinical Trials
Section 9CTD
Section 10ECTD
Section 11Dossier Preparation
Section 12Modules on Stability Study
Section 13EU Orphan Medicinal Products Regulation
Section 14Pharmacovigilance Program : ADR
Section 15Why PV Process
Section 16PSUR
Section 17PV: Risk Management
Section 18PV Program Implementation in EU