Agenda - Day 2 | EU Pharmaceutical Law Forum

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Registration

08:00 - 08:50

Registration

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Regulatory Frameworks

08:50 - 09:00

Opening Remarks from Morning Chair

09:00 - 09:30

KEYNOTE EU Commission Update

Legislative update from the EU Commission
Insights into EU Commission perspective on EU Competitiveness

Rainer Becker - Director for Medical Products and Innovation, DG SANTE, European Commission

09:30 - 10:10

Competing for Health Sovereignty: Strategies for a Reshaped Pharmaceutical Landscape

How are evolving US, EU, and Chinese policies transforming pharmaceutical manufacturing, trade, and pricing?
How can pharmaceutical companies innovate to ensure resilience and equitable access amidst geopolitical shifts

Bethany Hills - Partner, White & Case

10:10 - 10:40

KEYNOTE EMA Update

EMA restructuring under the General Pharmaceutical Legislation (GPL)
Insight into innovation policies at the EMA
New developments for the regulatory sandbox and platform approach

Georgia Gavriilidou - Head of the Legal Department, European Medicines Agency

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Networking

10:40 - 11:10

Morning Coffee

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Regulatory Frameworks

11:10 - 11:50

Key Changes in the General Pharmaceutical Legislation Impacting Incentives and Exclusivities

Latest developments on regulatory data and market protection
Exclusivity implications for orphan medicinal products, new indications
Definition of unmet medical needs
Expansion of the ‘Bolar’ exemption

Victoria Kitcatt - VP & Assistant General Counsel, Pfizer
Elise Melon - Global Legal Affairs, Head of Policy, Strategy and Operations, UCB (RDP)
Eveline Van Keymeulen - Partner, Latham & Watkins

11:50 - 12:20

Important New Obligations for MA Holders in the General Pharmaceutical Legislation

Obligations related to access, launch and supply
Imposed label changes, repurposing and implications
Paediatric medicines development

Charlotte Ryckman - Europe Head, Clinical R&D and Regulatory Legal, AbbVie
Victoria Kitcatt - VP & Assistant General Counsel, Pfizer

12:20 - 12:50

From Legislation to Implementation: Critical Areas for Attention

Pragmatic approaches for effective implementation
Key areas for industry to focus on in the next 2 years to ensure plausibility

Delphine Marchal - Associate Vice President, Assistant General Counsel, Regulatory Legal Team, International, Eli Lilly

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Networking

12:50 - 14:30

Networking Lunch

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Regulatory Frameworks

14:30 - 14:45

QUICK FIRE BRIEFING Shortage Management: New Regulatory Burden from Critical Medicines Act and New Pharmaceutical Legislation

Critical Medicines Act obligations and launch, supply and notifications requirements in the GPL
Key takeaways and impacts on company supply chains

Sophie Pelé - Partner, Dechert

14:45 - 15:00

QUICK FIRE BRIEFING on EU Commission Review of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) and AI Act

Key issues for the industry and the latest developments and proposed revisions to streamline the regulatory process

Senior Partner - ,, Arnold & Porter

15:00 - 15:40

Expectations and Implications of the Biotech Act

Anticipating the impact: how will this new legislative framework support early innovation?
Approaches to simplify clinical trial rules: changes to CTR, GMO legislation, and ATMP rules, while addressing challenges in genetic modification and trial phases
Funding mechanisms under Biotech Act: proposals for European and national funding opportunities
EU pilot for competitiveness: how will they expedite clinical trials and medical device projects?

Ioana Ratescu - Head of Legal Regulatory Europe & Development France & Iberia, Novartis Pharma
Claire Skentelbery - Director General, EuropaBio
Catherine Longeval - Partner, Van Bael & Bellis

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Networking

15:40 - 16:10

Afternoon Coffee

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Regulatory Frameworks

16:10 - 16:50

European Case Law Update: Latest from the EU Court of Justice and Landmark National Cases

Round-up of the latest case law and implications for the industry
Sanofi NAS case: how can regulatory authorities ensure consistent and transparent criteria for NAS designation to support innovation and fair market access?
Almirall case: does the case highlight gaps or ambiguities for compounding in regulatory frameworks for pharmaceuticals?
Tecfidera case: How can companies better align their regulatory strategies with their intellectual property protection efforts?

Sarah Forest - Senior Director - Regulatory Law EMEA, Johnson & Johnson
Stefano Marino - Senior Consultant, DLA Piper

16:50 - 17:30

Early Experiences from the HTA Regulation: Market Access Pricing and Reimbursement

First experiences of the industry with the Joint Clinical Assessment procedure (learnings, PICO scoping process, HTA dossier generation, explanation meeting, etc)
Navigating the Legal challenges and considerations in the JCA procedure
Are the economic models suitable for rare diseases? Are the economic models suitable for rare diseases?
To what extent will the HTA help with reimbursement discussion: early indications of Member States' response

Jennifer Ulbrich - Senior Legal Counsel, Roche
Caroline Stockwell - Vice President, Head of Legal – International, Amicus Therapeutics
Regina Skavron - Head of the Methodology and Co-ordination of European HTA Division, German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG)

17:30 - 17:35

Close of Day 2

Day 2Tuesday, 20 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

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