SIR ERA course module A 2021

Introduction to EU regulatory affairs

The first module of the ERA course focuses on understanding the basic structure of the regulatory system. We will discuss topics such as: the evolution of the regulation of medicines in the European Union (EU); the role of the European Medicines Agency (EMA) and national agencies; and the relevant legislative frameworks.


After this module you will be able to:

  • Summarize the EU’s role in public health, the goals of the internal market and how it relates to pharmaceuticals.
  • Outline the evolution of the regulatory system in Europe, including some historical pre-EMA procedures.
  • Identify the responsibilities of the EMA and understand how it is organized.
  • Summarize EMA’s role in current topics such early access to medicines, transparency of trial data and the legislation linked to it.
  • Outline the centralized procedure and other European registration procedures.
  • Describe lifecycle management of the benefit-risk profile of a medicinal product as a key activity of drug regulators.
  • Explain the necessity of collaboration between regulators, academia, HTA and clinicians to fuel policy & R&D decision-making.
  • Describe the scientific basis of regulatory affairs, and the necessity of regulatory science for innovation within the regulatory system and healthcare policy.
  • Understand the key challenges in the European legislative framework for medicines, and be able to name the most important court decisions, for example around the following:
    • New chemical entities and their legal implications
    • Parallel trade and re-packaging
    • Advertising
    • Off-label prescribing.

13-15 October 2021


The course is designed for professionals (from industry, academia and regulatory agencies) who want to boost their knowledge with the full range of technical, scientific and administrative requirements in the EU regulatory system for medicines.

New insights can be applied directly to the participant’s own organization.

Participants will preferably have previous university training in the biomedical or related disciplines, such as medicine, pharmacy, biochemistry, pharmacology and toxicology, although this is not an absolute necessity for the course.


Euro 1800,-- ex. VAT and overnight stay


Registration (in Dutch language, if this is not possible send an email)


Course manager: Thessa Bakker (

Over SIR

SIR Institute for Pharmacy Practice and Policy is een expertisecentrum voor de farmaceutische zorgpraktijk en beleid met toegewijde professionals die zich inzetten om veilig en effectief gebruik van geneesmiddelen te bevorderen.


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SIR Institute for Pharmacy Practice and Policy
Theda Mansholtstraat 5B
2331 JE Leiden

+31 71 5766157