TypeOnline Course
(1 ratings)
Price$390 / Rs. 19500
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Admission Process

Admission Process

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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
  • 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 3Overview of EU Regulation 
Lecture 4EMEA Procedures
Lecture 5Summary of Product Characteristics 
Lecture 6Compassionate Use
Lecture 7MHRA - UK Regulation 
Lecture 8The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 9EU Orphan Medicinal Products Regulation
Lecture 10Data exclusivity for pharmaceuticals in Europe
Lecture 11Patent Vs. Exclusivity
Lecture 12Accelerated assessment by EMEA
Lecture 13Conditional marketing authorisation
Lecture 14Master Data Maintenance by EMEA
Lecture 15Pre-authorisation GMP Inspection
Section 2Clinical Trials
Lecture 16Clinical Trials Terminologies 
Lecture 17
Lecture 18
Lecture 19Informed Consent
Lecture 20Clinical Data Publications
Section 3Drug Dossier Preparation and Submission
Lecture 21Detailed understanding of Drug Dossier
Lecture 22Advance Practical Training on Dossier Preparation
Lecture 23Modules on Stability Study 1
Lecture 24Review test on Stability Study
Lecture 25Module on Interchangeability 
Lecture 26Stability Testing of API 
Lecture 27Stability Testing of Finished Pharmaceutical Products
Lecture 28Review Test on Stability Testing 
Lecture 29Certificate of Analysis
Lecture 30Importance of effective dossier management
Lecture 31Deficiencies observed while preparing Dossiers
Section 4Pharmacovigilance Program
Lecture 32ADR Monitoring
Lecture 33Why Pharmacovigilance Process
Lecture 34PSUR : Detailed Understanding
Lecture 35Risk Management
Lecture 36PV Program Implementation in EU
Section 5Recent Update : European DRA
Section 6Final Examination