InstructorRoyed Training
TypeOnline Course
Price$490 USD / 24500 INR.
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European Drug Regulatory Affairs


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EU drug regulatory affairs course

The objective of European (EU) Drug Regulatory Affairs course is to provide training on Drug Regulatory Affairs and approval process in European Union (EU).

EU regulatory affairs course covers recent pharmaceutical regulations, marketing authorization procedure, country specific Common Technical Documents requirement. Moreover, comprehensive idea is provided how to prepare drug dossier as per EU CTD format. Moreover course focuses on the various marketing authorization pathways. Above all, course briefs on strategic planning for registration of pharmaceutical, biopharmaceutical in European Union.

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.

Course Code: RYD-011

Course Title: Advance Certification in European Drug Regulatory Affairs.

Online distance learning course. Hence, course can be accessed 24×7, across anywhere.

1 Month

Who should attend?

  • Regulatory Affairs professionals who are seeking to improve their skills in the European Drug 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.
  • Above all, this course is ideal for the business development managers working in pharmaceutical company, who are handling pharmaceutical business in European Union.

Any body who wants to acquire EU drug regulatory affairs competency should attend the course.

This European Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the EU pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

  • Orientation to practical understanding in the entire drug regulation, registration procedure of European Union. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations.
  • The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
  • Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
  • Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.

 Certificate will be provided at the end of the successful completion of the course

Few of the similar courses

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 17IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 18Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
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  
Lecture 25MHRA - UK Regulation 
Lecture 26The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 2Clinical Trial & Research
Lecture 27Clinical Trials Terminologies 
Lecture 28Clinical Trial Protocol Writing
Lecture 29Ethics in Clinical Research
Lecture 30Clinical data publication
Lecture 31Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3Dossier Preparation
Lecture 32Introduction to Common Technical Document (CTD)
Lecture 33Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 34Chemistry, Manufacturing & Controls 
Lecture 35Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 36Review Test on Stability Testing 
Lecture 37Importance of effective dossier management
Lecture 38Importance of effective dossier management
Lecture 39Discussion on 85 common deficiency in CTD submission dossier
Lecture 40Key Consideration for Drug Master File Preparation and Submission 
Lecture 41Practical Understanding on Drug Master File Preparation and Submission
Lecture 42Associated Learning: Site Master File - Detailed Understanding 
Lecture 43DMF Completeness Assessment
Lecture 44Drug Master File - Global Perspective [Across Different Regions]
Section 4Pharmacovigilance Program
Lecture 45Adverse Effect : Introduction
Lecture 46ADR Pharmacology
Lecture 47Classification of Adverse Effect
Lecture 48Adverse Effect
Lecture 49Why Pharmacovigilance Process
Lecture 50PSUR
Lecture 51Risk Management
Lecture 52How regulatory body adopt PV Program in EU?
Section 5Recent Update - Brexit