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Reliance and Work Sharing @ Work – State of Play and Hands-On Experience from Two Case Studies

Track:
Drug Development and Regulatory Approval - Reference Points around the Globe or Globalisation?

Day & Time:
April 18, 4:00PM - 5:30PM (Central Europe Standard Time)

Session Number:
S0803

Room Number:
Kairo 1-2

Level:
Advanced

Type:
Session

Title:
Reliance and Work Sharing @ Work – State of Play and Hands-On Experience from Two Case Studies

Chair(s):
Cordula Landgraf, RPh
Head of Networking
Swissmedic, Switzerland

Description:
Regulatory agencies around the globe increasingly rely on other regulators work products and embark on work sharing concepts to leverage resources and increase efficiency. What does that mean in practice and what are the experiences so far?

Presentation(s) & Speaker(s):
Setting the Scene: Introduction to Reliance and Work Sharing Initiatives
Cordula Landgraf, RPh
Head of Networking
Swissmedic, Switzerland

Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium
Michael L Banks, MSc
Senior Vice President Regulatory Affairs
Teva Pharmaceuticals Europe, United Kingdom

Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium
Chantal Pfaeffli, MPharm
Case Manager
Swissmedic, Switzerland

IGDRP Work Sharing Activities: Leveraging on the EU’s Centralised and Decentralised Procedure
Peter Bachmann, DrSc, PhD
Deputy-Head, European Union and International Affairs
Federal Institute for Drugs and Medical Devices (BfArM), Germany