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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
08:50 - 09:00
Opening Remarks from Morning Chair
- Eveline Van Keymeulen - Partner, Latham & Watkins LLP
09:00 - 09:30
KEYNOTE: EU Commission Update on the Regulatory Landscape
- Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission, European Commission
09:30 - 10:30
KEYNOTE PANEL: Industry Impact the EU Pharmaceutical Legislation Revision
- Stefano Marino - Head of Legal Services, European Medicines Agency
- Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission, European Commission
- Kristine Peers - General Counsel, European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Eveline Van Keymeulen - Partner, Latham & Watkins LLP
10:30 - 11:00
Networking Break
Showing 1 of 1 Streams
Regulatory Frameworks
11:00 - 12:00
KEYNOTE PANEL: Detailed Review of Proposals for Incentivising R&D in Unmet Medical Needs: General Pharmaceutical Legislation, Orphan, and Paediatric Regulations
- Peter Bogaert - Partner, Covington & Burling LLP
- Georgia Gavriilidou - Associate General Counsel, Amgen
- Victoria Kitcatt - VP & Assistant General Counsel, Pfizer
- Elise Melon - Head of Policy, Strategy & Operations, Global Legal Affairs, UCB
12:00 - 12:40
DUAL DIALOGUE: New Obligations and Liability for your Supply Chain
- Evi Mathiou - Legal, Compliance & Quality Director, Novo Nordisk
- Peter L'Ecluse - Partner, Van Bael & Bellis LLP
12:40 - 14:00
Networking Lunch
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Regulatory Frameworks
14:00 - 14:10
Opening Remarks from Afternoon Chair
- Christian Jervelund - Partner, Copenhagen Economics
14:10 - 15:10
PANEL: New HTA Regulations and Evolving Pharmaceutical Market Access Frameworks
- Ansgar Hebborn - Head, European Access Policy Affairs, Roche
- Christian Jervelund - Partner, Copenhagen Economics
- Matthias Heck - Attorney-at-Law, Senior Director, International TA Policy Strategy, Alexion Astra Zeneca Rare Disease
- Adela Williams - Partner, Arnold & Porter
15:10 - 15:50
TRI DIALOGUE: Regulatory Frameworks for Healthcare Systems Solutions and Market Access Strategies
- Ilja Moree - Head Legal Europe Innovative Medicines, Novartis AG
- Kirsten Broeckers - Vice President, Head Legal Affairs EMEA, Novartis Gene Therapies GmbH
- Jordi Faus - Managing Partner, Faus Moliner
15:50 - 16:20
Networking Break
Showing 1 of 1 Streams
Regulatory Frameworks
16:20 - 17:00
TRI DIALOGUE: The MDR and IVDR – Challenges and Opportunities
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
- Sophie Pelé - Regulatory Partner, Dechert LLP
- Amelie Chollet - Legal Regulatory Counsel, EMEA, Abbott
17:00 - 17:40
DUAL DIALOGUE: Reshaping Clinical Research with Health Data
- Martijn ten Bloemendal - Global Privacy Counsel, AbbVie
- Tine Carmeliet - Senior Associate, Allen & Overy LLP
17:40 - 18:40
Close of Day Followed by Networking Drinks Reception
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