RAPS Releases Updated Agenda for Forthcoming Regulatory Conference

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019, set to take place in Brussels on May 13–14, 2019.

Speakers from European authorities, notified bodies, and trade representatives are scheduled to speak at the conference on the changing European regulatory landscape. Among the speakers confirmed to participate in this year’s event are Erik Hannson from the European Commission (EC), Graeme Tunbridge from the Medicines and Healthcare products Regulatory Agency (MHRA), and Marie-Helene Pinheiro from the European Medicines Agency (EMA). A more comprehensive list can be found at the end of this story.

“Europe’s regulatory environment for medicines and medical technology is always evolving but we are now going through a period of major transition,” said RAPS executive director Paul Brooks. “The new Medical Device and In-VitroDiagnostic Regulations, impacts on pharmaceutical manufacturers of combination products and the uncertain future of Brexit present a unique and complex set of challenges for the European life sciences sector. It is vital for all stakeholders to engage in productive and informed dialogue. This conference presents an opportunity for regulators, thought leaders, and regulatory professionals to come together to discuss the critical questions, practical implications, and important steps ahead.”

A more comprehensive list of conference speakers includes:

• Erik Hansson, EC

• Bassil Akra, TÜV SÜD Product Service GmbH

• Olivier Bisazza, MedTech Europe

• Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subject

• Graeme Tunbridge, MHRA

• Valerie Nys, Federal Agency of Medicines and Health Products

• Maren von Fritschen, PhD, European Confederation of Pharmaceutical Entrepreneurs

• Henrike Potthast, BfArM

• Corine Delorme, GMED Group LNE

• Marie-Helene Pinheiro, EMA

• Andreas Stange, TÜV SÜD Product Service GmbH

• Armin Ritzhaupt, EMA

• Tim De Schutter, Federal Agency of Medicines and Health Products

• Kees Maqueline, Afdeling Medische Technoligie

• Katrien Martens, Federal Agency of Medicines and Health Products

• Waldo Weijers, Medicines Evaluation Board (NL)

If you would like to learn more about this upcoming conference then please read Pharmaceutical Technology Europe’s interview with Paul Brooks to be published soon in the May 2019 issue of the magazine.

Source: RAPS