Key Sessions
Luis Pinheiro
TRI DIALOGUE Regulatory Framework Developments for Artificial Intelligence
European Medicines Agency (EMA)
Florian Schmidt
KEYNOTE EU Commission Update on the Regulatory Landscape
European Commission
Pernille Weiss
KEYNOTE PANEL Exploring Progress on Proposals in the EU Pharmaceutical Legislation Revision
European Union’s Pharmaceutical Directive
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Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 2 - CET/CEST (Cent Europe Summer, GMT+2)
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Regulatory Frameworks
08:00 - 08:50
Registration
08:50 - 09:00
Opening Remarks from Morning Chair
- Eveline Van Keymeulen - Partner, Latham & Watkins
09:00 - 09:30
KEYNOTE EU Commission Update on the Regulatory Landscape
- Florian Schmidt - Principal Administrator, DG Health and Food Safety , European Commission
09:30 - 10:30
KEYNOTE PANEL Exploring Progress on Proposals in the EU Pharmaceutical Legislation Revision
- Pernille Weiss - MEP and Rapporteur, European Union’s Pharmaceutical Directive
- Elise Melon - Global Legal Affairs, Head of Strategy, Operations & Policy, UCB
- Kristine Peers - General Counsel, European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Eveline Van Keymeulen - Partner, Latham & Watkins
10:30 - 11:00
Networking Break
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Regulatory Frameworks
11:00 - 11:40
DUAL DIALOGUE Updates on Regulatory Protection and Enforcement of Regulatory Exclusivity Rights
- Peter Bogaert - Partner, Covington & Burling
- Victoria Kitcatt - VP & Assistant General Counsel, Pfizer
11:40 - 12:20
DUAL DIALOGUE Continuing Rise of the Use of Unapproved Products: Latest Developments and a Look Ahead
- Jonas Lind Hansen - Obesity Lead and Senior Corporate Counsel, Global Legal & Patents, Novo Nordisk
- Catherine Longeval - Partner, Van Bael & Bellis
12:20 - 13:40
Networking Lunch
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Regulatory Frameworks
13:40 - 13:50
Opening Remarks from Afternoon Chair
- Christian Jervelund - Partner, Copenhagen Economics, Copenhagen
13:50 - 14:35
PANEL Market Access Challenges and Developments for Pharmaceutical Firms
- Ilja Moree - Head Legal Oncology Region Europe, Novartis AG
- Jordi Faus - Partner, Faus Moliner
- Christian Jervelund - Partner, Copenhagen Economics, Copenhagen
14:35 - 15:15
TRI DIALOGUE Guidance and Risks for Decentralised Clinical Trials
- George Pickering - Vice-President and Head of Legal for Research, Development and MDS, GSK PLC
- Alison Dennis - Partner, Taylor Wessing
- Kim Rose - Vice President, Global Legal Operations, Lightship
15:15 - 15:45
DUAL DIALOGUE Progressing Advanced Therapy Medicinal Products (ATMPs) Regulatory Frameworks
15:45 - 16:15
Networking Break
Showing 1 of 1 Streams
Regulatory Frameworks
16:15 - 16:55
TRI DIALOGUE Regulatory Framework Developments for Artificial Intelligence
- Luis Pinheiro - Senior Epidemiology Expert, European Medicines Agency (EMA)
- Hilary Jones - Vice President Legal, Global Commercial & Regulatory Law at BioNTech, BioNTech UK Limited
- Sophie Pelé - Partner, Dechert
16:55 - 17:35
DUAL DIALOGUE Striking a Regulatory Balance for Companion Diagnostics: Analysing Tensions Between Pharmaceutical and IVDR Frameworks
- Xisca Borrás - Partner, Bristows
- Simone Heitz - Senior Legal Counsel, Merck
17:35 - 18:35
Close of Regulatory Frameworks Day Followed by Networking Drinks Reception
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