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Registry Studies: What Are the Expectations from the Regulators?

Track:
How Can We Enable Clinical Research in Europe Further?

Day & Time:
April 18, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:
S0902

Room Number:
Delhi

Type:
Session

Title:
Registry Studies: What Are the Expectations from the Regulators?

Chair(s):
Maren von Fritschen, PharmD
Managing Director
Addon Pharma GmbH, Germany

Description:
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.

Presentation(s) & Speaker(s):
What Are the Expectations from the Regulators?
Xavier Kurz, MD
Head of Surveillance and Epidemiology Service
European Medicines Agency, European Union, United Kingdom

Case Study on a Global Registry of Soliris (eculizumab) for an Additional Indication
Nadia Assenova
Sr. Director Regulatory Affairs, EMEAC
Alexion Pharma GmbH, Switzerland

Case Study on a CHMP Approval for an OMP on Accelerated Assessment Based on Registry Data
Chay Morgan
Vice President Regulatory Affairs EU
Biomarin (UK) Ltd., United Kingdom