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Registry Studies: What Are the Expectations from the Regulators?
Session Chair(s)
Maren von Fritschen, PHARMD
Drug Development and Regulatory Affairs - MSC Course, University of Applied Sciences, Germany
Registries can play an important role not only in monitoring the safety of medicines but also in providing adequate source for regulatory decision making. High quality patient registries can make valuable contributions to the evaluation and monitoring of medicines for public health benefit. The objective of the European Medicines Agency Patient Registry initiative is to facilitate discussions at an early stage in the authorisation procedure to increase use of existing patient registries and to support the creation of a new registry based on standard methodological approaches. This session will provide insides in challenges and opportunities for the use of registries in decision making processes based on case studies and the regulator’s expectations.
Speaker(s)
Xavier Kurz, MD, PHD, MSC
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
What Are the Expectations from the Regulators?
Nadia Assenova, LLM, MBA, MPHARM, MS
, Moderna Switzerland Gmbh, Switzerland
Chay Morgan
Vice President Regulatory Affairs EU, Biomarin (UK) Ltd., United Kingdom
Case Study on a CHMP Approval for an OMP on Accelerated Assessment Based on Registry Data
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