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Sign UpFrom Marketing Authorization to EU HTA and National Pricing Negotiations – Europe’s Rules are Changing
C5’s European Market Access Think Tank is a new forum examining how legal, HTA, pricing, and reimbursement frameworks, reshaped by the EU HTA Act and the forthcoming Pharma Reform Package, are redefining access to medicines across the EU and UK. The event will provide practical insight into navigating approvals, IP, HTA, and national reimbursement systems to support successful market access and formulary placement.
This conference welcomes senior legal, market access, pricing, HEOR, regulatory, and policy professionals from biopharma companies and life sciences law firms who are directly responsible for navigating how approved medicines achieve reimbursement and patient access across Europe.
Conference Co-Chairs
Marie Manley
Partner, Head of the UK Life Sciences Practice
Sidley Austin LLP
Alexandru Potlog
Senior Counsel, Global Legal Strategies & Policy
Abbvie
Featured Speakers
Hans Christian Cederberg Helms
Chief Consultant
Danish Medicines Council
Maya Matthews
Deputy Director & Head of Unit, Health Technology Assessment
European Commission
Mihai Iulian Rotaru
Director, Market Access
EFPIA – European Federation of Pharmaceutical Industries and Associations
Key Insights From
Robert Fairless
Vice President Legal International
Incyte Biosciences International Sàrl
Edith Frénoy
Director Market Access | Strategic HTA Coordination | AMNOG | EU Market Access
MSD Deutschland
Elisabeth Leimbacher
Global Legal Lead, Marketing & Commercial Excellence
Takeda
Debjani Mueller
Vice President
Health Technology Assessment international (HTAi)
Ioana Ratescu
R&D Legal Head Safety, Development Europe and International RA Legal Lead, Attorney at Law
Novartis Pharma AG
Advisory Board
Gain exclusive insights from our esteemed European Market Access Think Tank Advisory Board, whose expertise and guidance were instrumental in shaping this year’s comprehensive program.
Together, they will examine how legal, HTA, pricing, and reimbursement frameworks — evolving under the EU HTA Act and the forthcoming Pharma Reform Package — are redefining access to medicines across the EU and UK.
The event will deliver practical, forward-looking guidance on navigating regulatory approvals, IP strategy, joint and national HTA processes, and country-specific reimbursement systems to support successful market access and formulary placement.
View Advisory Board
Key Discussion Topics
Legislative Reform and Geopolitical Pressures
Shaping the Future of Market Access in Europe
Most Favored Nations Pricing
Global Ripple Effects on U.S. and EU Drug Markets
EU HTA Regulation in Practice
Early Lessons and What Comes Next
Pricing, Reimbursement and Economic Reality
Navigating Europe’s Diverse Market Landscape
Marketing Authorization and Post-Approval Strategy
Navigating EU and UK Pathways
Market Access and IP Rights
Optimising Regulatory and Exclusivity Protections
Supply Resilience, Generics and Compassionate Use
Rethinking Access, Equity and Availability in the EU
Who Should Attend
In-House Counsel and Legal Specialists from Pharmaceutical, Biotech, and Medical Device companies
Managers, Directors, and Executives from Pharmaceutical, Biotech, and Medical Device companies responsible for:
- Market Access
- Reimbursement & Pricing
- Regulatory, Policy & Government Affairs
- Commercial Strategy
- Health Economics / HEOR
- Health Technology Assessment / HTA
- Joint Clinical Assessment / JCA
- Medical Affairs
- External Affairs
- Patient Outcomes / Affairs
Law Firms who represent Pharmaceutical, Biotech, and Medical Device companies and/or who specialize in:
- Life Sciences Regulation
- Healthcare Regulation
- EU Law & Public Policy
- IP & Exclusivity
- Competition
Sponsors & Partners
Associate Sponsors
Media Partners
Sponsor Opportunities
With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, the Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.
For more information please contact:
Megan Gallagher
Business Development Manager • Sponsorship
Phone: +1 646-397-2931
Email: [email protected]
