The European Regulatory Affairs (ERA) course is organized by the SIR Institute for Pharmacy Practice and Policy and has been running for over 23 years. During this time we have created a strong faculty of experts in industry, academia and regulatory bodies – and we have trained over 400 regulatory affairs professionals. Today, the SIR ERA course is seen as an established learning vehicle for professionals in regulatory affairs, both in industry and government.

Who is it for?
The ERA course is designed for professionals from industry, academia and regulatory agencies who want to boost their knowledge by getting acquainted 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 ideally have previous university training in biomedical or related disciplines, including medicine, pharmacy, biochemistry, pharmacology and toxicology. However this is not an absolute requirement for the course.

Why should you take this course?
SIR offers this course to give you a broad overview on European regulatory affairs, while also providing hands-on experience with actual case studies. The ERA course also addresses broader developments in Pharma R&D and healthcare that are relevant for the future of the regulatory field.

Because of the diversity of participants and the interactive nature of the course, you will also strengthen your network and gain insight in diverse perspectives on the field. Above all, the SIR ERA course will help you to become a better informed and more effective professional.

We look forward to welcoming you as a participant!

Hans van Bronswijk, MD, PhD

Mrs. Thessa M. Bakker-Krol
Course Manager