SIR European Regulatory Affairs Course

ERA course 2018-2019:
Module A: 8-10 May 2019
Module B: 9-11 October 2019
Module C: 15-17 January 2020
Module D: 4-6 March 2020
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Module A: Foundations of the EU regulatory system

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. Read more...

Module B: Quality & pre-clinical part of the dossier

The second module discusses two important elements of the Common Technical Document (CTD): quality and non-clinical studies. Good manufacturing and distribution practices (GMP and GDP), pharmacology, toxicology and quality by design will be some of the topics discussed here. Read more...

Module C: Clinical part of the dossier

The third module is on clinical studies. We will discuss the clinical part of the Common Technical Document, e.g. how clinical development plans are made; how to interpret clinical data; and how to make a benefit-risk analysis. Read more...

Module D: On the edge of pre- and post-marketing

Finally, module D discusses trends and topics on the edge of the pre- and post-marketing environments. These include (current) developments in HTA; pricing and reimbursement; and use of medicines (e.g. adherence, off-label use and safety monitoring). Read more...

About SIR

SIR Institute for Pharmacy Practice and Policy is an expertise centre with a strong involvement in pharmacy practice research, education and health policy issues.

Read more on the SIR website (in dutch).

Get in touch

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

+31 71 5766157

secretariaat@sirstevenshof.nl