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Reliance and Work Sharing @ Work – State of Play and Hands-On Experience from Two Case Studies
Session Chair(s)
Cordula Landgraf, RPH
Head of Networking
Swissmedic, Switzerland
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?
Speaker(s)
Setting the Scene: Introduction to Reliance and Work Sharing Initiatives
Cordula Landgraf, RPH
Swissmedic, Switzerland
Head of Networking
Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium
Michael L Banks, MSC
Teva Pharmaceuticals Europe, United Kingdom
Senior Vice President Regulatory Affairs
Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium
Chantal Walther, MPHARM
Swissmedic, Switzerland
Head Regulatory Assessment Unit 4
IGDRP Work Sharing Activities: Leveraging on the EU’s Centralised and Decentralised Procedure
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Retired from Head International Liaison Office and Conferences, Executive Depart