Draft Agenda. Wednesday, 14 March Alexander Natz, Secretary General, EUCOPE Maarten Meulenbelt, Partner, Sidley Austin LLP

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1 Wednesday, 14 March :00 Welcoming Remarks 10:00 10:30 EU Pharmaceutical Case Law Overview of recent Pharmaceutical case-law Perspective of the Legal Service Impact to life sciences industry Markéta Šimerdová, European Commission Legal Service* 10:30 11:00 New EU Pharmacovigilance Legislation Overview of major changes introduced by the new rules Latest updates, including EMA s implementation plan Global impact for pharmaceutical companies Christopher Foreman, Merck Sharp & Dohme (Europe) Inc.* 11:00 11:30 The EU Comitology Rules 11:30 12:00 Coffee Break Delegated and Implementing acts; nature and difference Transitioning to the new Lisbon decision-making process Overview of transition deadlines and a brief summary of the current state of transition Impact on industry Anastasia Alvizou, DG Health and Consumers, European Commission *To be confirmed

2 Wednesday, 14 March 12:00 12:30 Latest Regulatory Developments in France and Germany France The new provisions regarding Temporary Use Authorisation (ATU - Autorisation Temporaire d'utilisation) Off-label use and RTU (Recommandation Temporaire d'utilisation / Temporary Use Recommendation) Limits imposed on Pharmaceutical sales representatives Germany Health Technology Assessment (HTA): Early benefit assessments Consequences of Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) for orphan drugs 16 th Drug Law Amendment: Implementation of recent EU legislation (Falsified Medicines/Pharmacovigilance) Marie-Geneviève Campion, Economic Adviser, EUCOPE Matthias Heck, Legal Counsel EU Affairs, EUCOPE 12:30 13:00 Regulatory Exclusivities 101 An Overview of Main Rules and Some Recent Judgments Lunch Regulatory Data Protection and Marketing Protection Supplementary Protection Certificates (SPC) Orphan Drug Exclusivity Pediatric Rewards Carl-Michael Simon, EU Regulatory Lawyer, Celgene 14:00 14:30 Tackling the threat of Falsified Medicines EU Falsified Medicines Directive: implementation The Commission's Public Consultations under the EU Falsified Medicines Directive Action against illegal internet pharmacies Hugh Pullen, Associate Director of EU Government Affairs, Eli Lilly *To be confirmed 2

3 Wednesday, 14 March 14:30 15:00 Review of the Transparency Directive 89/105/EEC Policy objectives Overview of the proposed changes and impact on industry Interplay with Health Technology Assessment (HTA) and national agreements Timeline for adoption of Proposal and beyond Thomas Heynisch, DG Enterprise and Industry, European Commission 15:00 15:30 A Paediatrics Update 15:30 16:00 Coffee Break The recent Nycomed decisions and related issues Analysis and consequences of the decisions Impact from industry s perspective Ray Cresswell, Vice President, Legal Operations R&D, GlaxoSmithKline 16:00 16:30 Future Trends in Clinical Development Henk Schuring, European Head of Regulatory, Genzyme 16:30 17:15 Legal Aspects of Good Manufacturing Practice Panel Discussion Raymond Bonner, Partner, Sidley Austin LLP Ann Showalter, GlaxoSmithKline Biologicals* 17:15 Closing Remarks *To be confirmed 3

4 Thursday, 15 March :00 Welcoming Remarks 9:00 9:30 The Upcoming Revision of EU Risk Assessment Processes Overview of the Commission s Preliminary Opinion and Public Consultation The benefits of a transparent and balanced risk benefit assessment policy Risks and impact for the pharmaceutical industry Alberto Alemanno, Associate Professor of Law, HEC Paris (École des Hautes Études Commerciales de Paris) 9:30 10:00 Latest Developments in Biosimilars Revision of overarching biosimilars guidelines Opportunities, barriers, and perceptions from the industry s perspective Impact of new pharmacovigilance rules Thomas Bols, Vice President Corporate Health Policy and Market Access, Merck Serono 10:00 10:30 The New EU Data Protection Rules 10:30 11:00 Coffee Break Why did the EU Commission propose a new Regulatory Framework? Overview of the Proposed Regulation and process towards adoption Impact on the Life Sciences industry George Rossides, DG Justice, European Commission *To be confirmed

5 Thursday, 15 March 11:00 11:30 Overview of Emerging Pricing and Reimbursement Practices UK proposals for value-based pricing of products Impact of French Healthcare reforms on pricing and reimbursement European Commission perspective on pricing and reimbursement and Health Technology Assessment (HTA) coordination Impact of Post Authorisation Safety Studies and Post Efficacy Studies (PASS/PAES) on pricing and reimbursement Melody Hamel, Senior Legal Counsel, Bayer 11:30 12:00 The Early Benefit Assessment for Orphan Drugs According to AMNOG in Germany 12:00 13:00 Lunch First experiences Esbriet (Pirfenidon) How to cope with IQWIG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) and GBA (Gemeinsamer Bundesausschuss) Katharina Scholz, EU General Counsel, Grifols 13:00 13:30 Recent Procedural Changes and Future Trends at the European Patent Office: Impact on the Patenting of Pharmaceuticals The EPO and its department responsible for pharmaceutical patents Overview of recent procedural changes Future developments and the unitary patent Streamlining the procedure Enrico Luzzato, Director of the Pure and Applied Chemistry Directorate European Patent Office 13:30 14:30 Competition Aspects of Pharmaceutical Law Panel Discussion Update from the Commission The interplay between regulatory and competition rules Patenting practices and IP enforcement Recent cases on introduction of generics Henri Piffaut, DG Competition, European Commission Nicolas Petit, Professor of Competition Law, Université de Liège Angela Staunton, Global Antitrust Counsel, Bayer HealthCare Kristina Nordlander, Partner, Sidley Austin LLP (moderator) *To be confirmed 5

6 Thursday, 15 March 14:30 15:00 European Innovation Partnership on Active and Healthy Ageing Maria Iglesia-Gomez, DG Health and Consumers, European Commission 15:00 15:30 Coffee Break 15:30 16:00 Life Sciences and Social Media Regulatory and legal issues in social media Dealing with liability in social media Latest cases and guidance on social media Lisa Howell, Association of the British Pharmaceutical Industry (ABPI) William Long, Counsel, Sidley Austin LLP 16:00 16:30 Transparency and Access to Documents in EU Law 16:30 Closing Remarks The principle of transparency in EU law; case-law developments on Regulation (EC) 1049/2001 The recommendations of the European Ombudsman to the EMA in Cases 2560/2007/BEH and 2493/2008/FOR The challenge of a new approach to administrative transparency in the Information Age Alessandro Spina, EMA Legal Service *To be confirmed 6