EU Fundamentals Online Learning Module:
The Online Learning Module will be available from 10 December.

Introduction to the EU : Peter Bachmann

• EU countries/ EU languages
• Roles and Responsibilities of European Institutions
• EU legislative framework concerning medicinal products

EU Licensing Procedures – Part 1 : Peter Bachmann

• Marketing Authorizations in the EU – the basics
• National Procedures
• Mutual Recognition Procedure
• Decentralized Procedure

EU Licensing Procedures – Part 2 : Anna Hammerbacher

• Centralised Procedure
• Conditional Approval
• Approval under exceptional circumstances
• Accelerated Assessment
• Post-Marketing Requirements
• Comparison to US and PMDA procedures
• Case Studies

Live Online Training

The live virtual training will be held on 14 and 16 January 2026 4-6PM (KST/JST), 3-5PM (SGT/CST). Additional live sessions may be opened depending on the number of registrants.

[Live-online Session Day 1 – Anna Hammerbacher]

Life Cycle of a Medicinal Product: From early development to market access and post-marketing 

• Early Clinical Trials – First in Human and Phase I
• Scientific Advice
• Later Stage Clinical Trials – Phase II and Phase III
• Marketing Authorisation
• Health Technology Assessment
• Variations
• Renewal
• Pharmacovigilance
• Case Studies 

Specific Medicinal Products 

• Paediatric Medicinal Products
• Orphan Medicinal Products
• ATMPs
• Case Studies

Questions and Answers Session 

[Live-online Session Day 2 – Peter Bachmann]

Variations/Post-Approval Changes 

• Definition of a variation – why are variations necessary
• Variation classification – working with the classification guideline
• Procedural guidance
• Renewals 

Pharmacovigilance 

• Pharmacovigilance legislation
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Risk Management Plan
• Post-Authorisation Safety Studies (PASS)
• Periodic Safety Update Report (PSUR)
• Safety Procedures/Referrals
• Expedited Reporting
• EU QPPV
• Pharmacovigilance System Master File (PSMF) 

Questions and Answers Session

This program is ideal for professionals involved in global drug development, regulatory strategy, and market authorization, particularly those seeking to expand their understanding of the European regulatory framework.

It is designed for:

• Regulatory Affairs professionals working with global submissions or managing EU-related projects

• Clinical development and pharmacovigilance specialists who need to understand EU requirements

• Market access and strategic planning managers aiming to align regulatory and reimbursement strategies

• Industry newcomers or regional teams looking to gain structured, practical insight into the EU licensing procedures and fast-to-market pathways

Whether you are developing small molecules, biologics, or advanced therapy medicinal products (ATMPs), this course provides the essential knowledge and tools to navigate the complex European regulatory landscape effectively.

- Gain a clear understanding of the European regulatory framework and the roles of key EU regulatory bodies.

- Compare and evaluate the major EU licensing routes, including their processes, timelines, advantages, and limitations.

- Understand specific regulatory pathways for orphan drugs, pediatrics, and advanced therapies (ATMPs).

- Strengthen foundational knowledge in core EU regulatory topics such as pharmacovigilance, scientific advice, clinical trials, variations, and data/market exclusivity.

- Apply regulatory principles to real-world global development scenarios through case studies and pre-learning modules to build effective EU regulatory strategies.