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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

Registry Studies: What Are the Expectations from the Regulators?

Session Chair(s)

Maren  von Fritschen, PharmD

Maren von Fritschen, PharmD

Head EU Regulatory Policy

Moderna, Netherlands

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

What Are the Expectations from the Regulators?

Xavier Kurz, MD, PhD, MSc

European Medicines Agency, Netherlands

Head of Data Analytics Workstream

Nadia  Assenova, LLM, MBA, MPharm, MS

Nadia Assenova, LLM, MBA, MPharm, MS

Moderna Switzerland Gmbh, Switzerland

Chay  Morgan

Case Study on a CHMP Approval for an OMP on Accelerated Assessment Based on Registry Data

Chay Morgan

Biomarin (UK) Ltd., United Kingdom

Vice President Regulatory Affairs EU

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