Work-in-progress seminar
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)