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This seminar addresses pressing challenges facing pharmaceutical regulation. First, the growing acknowledgement of patient-centered pharmaceutical care raises questions for many regulators about how to safeguard the independence of regulators, and the rigor and representativeness of clinical and other data they use in the process. This seminar examines questions about regulatory decision making that appropriately takes account of patients, their preferences, their (unmet) needs, and their (real world) data. Second, globalization and regionalization position the EU and its regulator, the European Medicines Agency, as influential actors in the governance of pharmaceutical safety and efficacy worldwide. This seminar focuses on ongoing research into the EU’s impact on pharmaceutical regulation in low- and middle-income countries.
Event details of Legal and policy challenges to pharmaceutical regulation
9 January 2024
09:30 -13:00

This seminar brings together ongoing or recently completed research on legal and policy aspects of regulatory decision making that are relevant for multiple jurisdictions. It is part of the NWO veni project Global Access to Medicines through EU Law & Policy.

Registration (free of charge) is required for this in-person event.


9:30 Round of introductions

Patient stories in regulatory decision making

Dr. Tineke Kleinhout-Vliek, Utrecht University

Representing patient interests in public policy: Is industry funding a concern?

Prof. Barbara Mintzes PhD, University of Sydney

Lex Sex – Regulatory perspectives on women in clinical trials

Dr. Jakob Wested, University of Copenhagen/Danish Medicines Agency

10:45-11:00 Break

EMA and FDA use of Real World Data: comparing the data and definitions

Kaat van Delm LLM, KU Leuven

Are innovative medicines authorized by the EU also approved in developing countries?

Dr. Katrina Perehudoff and Majd Alshoufi BPharm MSc, University of Amsterdam

External trust in the EMA: Implications for access to vaccines in Least Developed Countries

Pramiti Parwani LLM, University of Amsterdam

Patient safety in low- and middle-income countries: the role of EMA advice to withdraw medicines

Séraphine Bruinsma BSc, Vrije Universiteit Amsterdam

12:00-13:00 Lunch (provided)


Roeterseilandcampus - building A

Room A3.01
Nieuwe Achtergracht 166
1018 WV Amsterdam