戻る Agenda
Promising digital tools for simplifying variations- how to connect dots and to make it happened?
Session Chair(s)
Beata Stepniewska, MPHARM
Deputy Director , Head of Regulatory Affairs
Medicines for Europe, Belgium
The current regulatory framework for maintaining medicines and vaccines on the market needs to evolve to better reflect the scientific and technical progress and ensure improved operational efficiency in line with the objective of Better Regulation.
Learning Objective : Session participants will learn about challenges and limitations of the current EU variation regulation, its impact on the current approach to lifecycle management of medicinal products and potential improvements that may be made to ensure it is fit for purpose for the future. Participants will have the opportunity to discuss their own views of these challenges and proposed solutions.
Speaker(s)
Why is now the right time to modernize the EU variations System?
Beata Stepniewska, MPHARM
Medicines for Europe, Belgium
Deputy Director , Head of Regulatory Affairs
What are the challenges and future opportunities to manage post-approval changes?
Simon Bennett, MSC
Biogen, United Kingdom
Director, EU Regulatory Policy
How to use digital tools in variations’ reporting?
Remco Munnik
IRISS Forum, Spain
President
The UNICOM-Project - a central part in the jigsaw called ‘simplification’
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Retired from Head International Liaison Office and Conferences, Executive Depart
Panelist:
Georg Neuwirther, MS, MSC
Austrian Medicines & Medical Devices Agency (AGES), Austria
IT Director