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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)
Cordula Landgraf, RPH
Head of Networking, Swissmedic, Switzerland
Setting the Scene: Introduction to Reliance and Work Sharing Initiatives
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 Walther, MPHARM
Head Regulatory Assessment Unit 4, Swissmedic, Switzerland
Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany
IGDRP Work Sharing Activities: Leveraging on the EU’s Centralised and Decentralised Procedure
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