DIA EUROPE 2018

Back to Agenda

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

Deputy-Head, European Union and International Affairs

Have an account?

DIA EUROPE 2018

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

Session Chair(s)

Cordula Landgraf, RPh

Speaker(s)

Setting the Scene: Introduction to Reliance and Work Sharing Initiatives

Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium

Regulator’s and Applicant’s View on the First Generic Medicines Work Sharing Trial (GMWST) of the ACSS Consortium

IGDRP Work Sharing Activities: Leveraging on the EU’s Centralised and Decentralised Procedure

Be informed and stay engaged.