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Wednesday 18th May - CET/CEST (Cent Europe Summer, GMT+2)
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Wednesday 18th May - CET/CEST (Cent Europe Summer, GMT+2)
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08:00 - 08:4545 mins
Conference Registration
08:45 - 08:505 mins
Regulatory Frameworks
Opening Remarks by the Morning Chairperson
- Eveline Van Keymeulen - Partner, Latham & Watkins
08:50 - 09:3040 mins
Regulatory Frameworks
KEYNOTE EU Commission Update on the Regulatory Landscape
- Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission
09:30 - 10:3060 mins
Regulatory Frameworks
KEYNOTE PANEL Key Industry Takeaways from the Ongoing Pharmaceutical Legislative Reviews
- Victoria Kitcatt - Vice President and Assistant General Counsel, Pfizer
- Elise Melon - Legal Chief of Staff, Head of IP Policy & Operations, UCB
- Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission
- Eveline Van Keymeulen - Partner, Latham & Watkins
- Marie Manley - Partner & Head of the UK Life Sciences Practice, Sidley Austin LLP
10:30 - 11:0030 mins
Networking Break
11:00 - 11:3030 mins
Regulatory Frameworks
KEYNOTE EMA Update: Cooperation and Data Sharing Between Regulators
- Martin Harvey - Head of International Affairs, European Medicines Agency (EMA)
11:30 - 12:1545 mins
Regulatory Frameworks
Industry Implications of the European Health Emergency Preparedness and Response Authority (HERA)
- Kristine Peers - General Counsel, EFPIA
- Peter Bogaert - Partner, Covington & Burling LLP
12:15 - 13:2570 mins
Networking Lunch
13:25 - 13:305 mins
Regulatory Frameworks
Opening Remarks from Afternoon Chairperson
- Jordi Faus - Partner, Faus & Moliner
13:30 - 14:1040 mins
Regulatory Frameworks
DUAL DIALOGUE Expanding Possibilities for Off-Label Use of Medicines & Regulatory Considerations on Related Topics
- Catherine Longeval - Partner, Van Bael & Bellis
- Evi Mathiou - Legal, Compliance & Quality Director, Novo Nordisk
14:10 - 14:5040 mins
Regulatory Frameworks
DUAL DIALOGUE DUAL DIALOGUE Implications of the EU Clinical Trial Regulation (EU CTR)
- Elisabethann Wright - Partner, Cooley
- Claudia Muttin - Global Legal Lead – Prescription Global Business Unit, Galderma
14:50 - 15:3040 mins
Regulatory Frameworks
DUAL DIALOGUE New Developments in the Regulation, Conduct and Use of Real-World Evidence
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
- Jacqueline Mulryne - Partner, Arnold & Porter
15:30 - 16:0030 mins
Networking Break
16:00 - 16:5050 mins
Regulatory Frameworks
PANEL DISCUSSION A New Regulatory Frontier: EU AI Regulations
- Gabriele Mazzini - Team Leader - Artificial Intelligence Policy & Regulation, DG Connect, European Commission (subject to confirmation)
- James Clark - Senior Associate, DLA Piper
- Alejandro Bes - Global Senior Legal Counsel, Digital, Novartis
- Ulrich Juknat - Legal Director – Regulatory Law, EMEA, Johnson & Johnson Medical GMBH
16:50 - 17:4050 mins
Regulatory Frameworks
PANEL Evolving Pharmaceutical Market Access Frameworks
- Georgia Gavriilidou - Associate General Counsel, Amgen
- Sophie Pelé - Partner, Dechert LLP
- Christian Jervelund - Partner, Copenhagen Economics
- Arianna Greco - SVP, Head of Global Commercial Legal, Alnylam Pharmaceuticals
17:40 - 18:1030 mins
Close of Regulatory Frameworks Day Followed by Networking Drinks Reception
17:45 Registration • 18:00 Start • 20.00 End
18:10 - 20:25135 mins
Evening Seminar - Effective Market Access: Understanding HTA and Practical Negotiation Tips
Effective Market Access: Understanding HTA and Practical Negotiation Tips
- Marie Manley - Partner & Head of the UK Life Sciences Practice, Sidley Austin LLP
- Zina Chatzidimitriadou - Managing Associate, Sidley Austin LLP
- Chris Boyle - Senior Managing Associate, Sidley Austin LLP
- Simon Costello - Associate General Counsel, UCB
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