Meet the teams from BfArM, Paul-Ehrlich-Institut and BVL - partners of the TOPRA symposium - at our joint stand and in the following sessions:

JW Marriott Hotel, Stauffenbergstrasse 26, Berlin

Mon 29 September 2025

Human Medicines Programme

• 11:45-12:00: "Welcome Speech" with Prof. Dr. Karl Broich, President of BfArM, Prof. Dr. Stefan Vieths, President of Paul-Ehrlich-Institut and Dr. Samantha Atkinson, CEO of TOPRA
• 12:00-13:30: "HM1 - General Pharmaceutical Legislation: Platform Technology and Sandbox Approaches", Prof. Dr. Karl Broich, BfArM and Prof. Dr. Stefan Vieths, Paul-Ehrlich-Institut, et al.
• 14:45-16:15: "HM2 - Fireside Chat", Prof. Dr. Karl Broich, BfArM, et al.
• 16:45-18:15: "HM3 - Applying Artificial Intelligence in Real-Life", Dr. Martin Huber, BfArM and Larissa Kopp, Paul-Ehrlich-Institut, et al.

Veterinary Medicines Programme

• 11:20-11:30: "Welcome Speech", with Prof. Dr. Thomas Heberer, BVL and Rick Clayton, Ex-Technical Director at HealthforAnimals
• 11:30-13:00: "VM1 - Meeting the objectives of the Regulation", Prof. Dr. Thomas Heberer, BVL, et al.
• 14:30-16:00: "M2 - Regulatory updates", Prof. Dr. Thomas Heberer, BVL, et al.

Tue 30 September 2025

Medical Devices & IVD Programme

• 11:00-11:10: "Welcome Speech" with Prof. Dr. Karl Broich, President of BfArM, Prof. Dr. Zoe Waibler, Acting Vice President of Paul-Ehrlich-Institut and Ashleigh Batchen, TÜV SÜD UK
• 14:00-15:00: "MD2/IVD2 - Clinical Investigations with Medical Devices", Dr. Ulf Schriever, BfArM, et al.

Human Medicines Programme

• 11:10-12:40: "HM5/MD1/IVD1 - Programme COMBINE – Accelerating Access to Clinical Trials and Medical Innovation in the EU", Dr. Hilke Zander, Paul-Ehrlich-Institut, et al.

Veterinary Medicines Programme

• 12:45-13:40: "VM6 - Transitioning to Animal-Free Chemical Safety Testing for Veterinary Medicines", Dr. Esther Werner, Paul-Ehrlich-Institut and Dr. Sarah Adler-Flindt, BVL, et al.

Wed 1 Oktober 2025

Medical Devices & IVD Programme

• 11:00-12:00: "MD6 - The Importance of Digital Health: Digital Health Applications (DiGA) and Digital Mental Health Technology Project", Prof. Dr. Wolfgang Lauer, et al.
• 11:00-12:00: "IVD6 - The Evolution of the In Vitro Diagnostic Regulation", Laura van Diepen, BfArM and Steffen Luckner, BMG, et al.
• 13:00-14:00: "MD7 - Clinical Investigations with Medical Devices", Steffen Luckner, BMG, et al.
• 13:00-14:00: "IVD7 - EU Reference Laboratories One Year On", Prof. Dr. Karin Metzner, Paul-Ehrlich-Institut, et al.
• 14:00-15:00: "MD8 - Post-Market Challenges for Medical Devices", Dr. Ekkehard Stößlein, BfArM, et al.

Human Medicines Programme

• 09:30-11:00: "SME1 - Regulatory Updates for SME, Academia and Start-ups", Dr. Nadine Kirsch-Stefan, Paul-Ehrlich-Institut, et al
• 11:30-13:00: "HM9 - From Barrier to Bridge: Practical Strategies for Successful Advanced Therapy Medicinal Product (ATMP) Development", Dr. Jens Reinhardt and Dr. Ralf Sanzenbacher, Paul-Ehrlich-Institut, et al.
• 11:30-13:00: "PS1 - Tailored Development of Biosimilars without Efficacy and Safety Studies: Is this The Future?", Dr. Nils Jost, Paul-Ehrlich-Institut, et al.
• 14:15-15:45: "HM10 - Strengthening Europe’s Clinical Trial Competitiveness", Dr. Claudia Riedel, BfArM and Dr. Andreas Bonertz, Paul-Ehrlich-Institut, et al.