Innovatief, deskundig en betrokken

SIR ERA course 2024-2025 | Module B

  • 25-27 September 2024
  •  2.050,00 excl. BTW
  • Estate Oud Poelgeest

Doelgroepen en accreditatie:
Professionals from industry, academia and regulatory agencies (accreditation not applicable)

Not applicable

Module A: 5-7 June 2024
Module B: 25-27 September 2024
Module C: 20-22 November 2024
Module D: 29-31 January 2025

Registration fee: overnight stay not included

See the programs of the individual modules

Thessa Bakker

In het kort (In short):
The European Regulatory Affairs (ERA) course is organized by the SIR institute of Pharmacy Practice and Policy and has been running for over 23 years. We are proud to say we have trained over 400 regulatory affairs professionals since. During these years, we have obtained a strong faculty of leading figures in industry, academia and regulatory bodies (both at a national level as well as at the EMA). The SIR ERA course is viewed by leading authorities as an established learning vehicle for professionals in regulatory affairs, both in industry and government.

Leerdoelen (Learning goals):
SIR offers this course to give you a broad overview on European regulatory affairs, while also providing hands-on experience with actual cases. Furthermore, the ERA course addresses developments in pharma R&D and healthcare that are relevant for the future of the regulatory field.

Beyond the course, you will strengthen your network and gain insight in diverse perspectives on the field, due to a high variety of participant and speaker background, as well as the interactive features of the course.


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.

All together, the SIR ERA course will help you to become well informed and thus a more effective professional.

Download: Brochure about the course with information about the different modules:
Module A: Introduction to EU regulatory affairs | Program
Module B: The Quality & Pre-clinical part of the dossier
Module C: The Clinical part of the dossier
Module D: On the edge of pre- and post-marketing