WELCOME COCKTAIL WITH LEGAL EXPERTS PRESENT AT THE 14 th MEDICINES FOR EUROPE LEGAL CONFERENCE REGISTRATION AND WELCOME COFFEE

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1 WEDNESDAY 25 APRIL WELCOME COCKTAIL WITH LEGAL EXPERTS PRESENT AT THE 14 th MEDICINES FOR EUROPE LEGAL CONFERENCE THURSDAY 26 APRIL REGISTRATION AND WELCOME COFFEE OPENING ADDRESS KEYNOTE SPEECH SESSION 1 - BIOLOGIC MEDICINES ECOSYSTEM: OUTLOOK 2030 Marc-Alexander Mahl, President - Keith Ridge, Chief Pharmaceutical Officer - NHS England Moderator: Adrian van den Hoven, Director General - Dirk Van den-steen, Policy Officer, DG SANTE - European Commission Per Troein, Vice President Strategic Partners - IQVIA Justin Stebbing, Professor of Cancer Medicine and Oncology, Consultant Oncologist - Imperial College and Imperial College Healthcare NHS Trust, UK Robert Andrew Johnstone, Patient Advocate - International Foundation for Integrated Care (IFIC), European Forum for Good Clinical Practice (EFGCP) & Health Quality Improvement Partnership (HQIP) Carol Lynch, President - Sandoz US, Head of North America and Chair of the Biosimilar Medicines Group of SESSION 2 - OPTIMISING ACCESS MODELS: MOVING FROM PROBLEMS TO SOLUTION THROUGH CONCRETE ACTIONS Moderator: Aidan Fry, Editor - Generic Bulletin, Informa A medicines for europe sector group Rue d Arlon Brussels - Belgium T: +32 (0) F: +32 (0) P a g e 1

2 András Inotai, Principal Researcher, Head of Pharmaceutical Policy Department - Syreon Research Institute Uwe Gudat, Head of Clinical Safety & Pharmacovigilance - Fresenius-Kabi SwissBioSim Pontus Johansson, Senior Analyst and Head of Unit - TLV, Sweden Gustaf Befrits, Administrator / Health Economist - Stockholm County Council, Sweden David Willows, Chief Innovation and Marketing Officer, Green Shield, Canada Brian Lehman, Strategic Consultant, Pharmacy Professional Affairs - Humana Pharmacy Solutions, USA NETWORKING BUFFET LUNCH SESSION 3 - SUSTAINABLE PROCUREMENT PRACTICES: EXPERIENCE GAINED Moderator: Florian Turk, Global Head Payor Marketing, Sales and Engagement - Sandoz and Vice-Chair of the Market Access Committee - Biosimilar Medicines Group, a Medicines for Europe Sector Group An Baeyens, Legal and Policy Officer, Directorate General Internal Market, Industry, Entrepreneurship and SMEs - European Commission Yves Verboven, Director Market Access & Economic Policies - MedTech Europe Philippe Lechat, Physician, Cardiologist and Professor of Pharmacology - Paris Diderot University, France Jan de Buhr, Head of Commercial Procurement - McKesson Europe AG SESSION 4 - CARING FOR PATIENTS WITH CANCER TODAY AND TOMORROW SEIZING THE BIOSIMILAR MEDICINES OPPORTUNITY Moderator: Suzanne Wait, Managing Director - The Health Policy Partnership Ltd, UK Rabia Khan, Policy Analyst - OECD Murray Aitken, Senior Vice President at IQVIA and the Executive Director - IQVIA Institute for Human Data Science Zorana Maravic, Director of Group and Project Development - EuropaColon Johan De Munter, Nurse Consultant Hematology - HSCT University Hospital Ghent and EONS Board Member Rosa Giuliani, Consultant in Medical Oncology - Oncology Dept of S. Camillo-Forlanini Hospital, Rome Erin Federman, Head of Biologics, Europe - Mylan P a g e 2

3 CLOSING SPEECH Simona Montilla, Pharmaceutical Policy Expert and HTA Assessor - Italian Medicines Agency (AIFA) NETWORKING COCKTAIL FRIDAY 27 APRIL NETWORKING WELCOME COFFEE KEYNOTE SPEECH Jayasree K. Iyer, Executive Director - Access to Medicine Foundation SESSION 5 - ADVANCING REGULATORY SCIENCE Moderator: Christian Schneider, Director - National Institute for Biological Standards and Control (NIBSC), UK Quality comparability: Martin Schiestl, Chief Science Officer - Sandoz Biopharmaceuticals, Austria Global reference product: Gillian Woollett, Senior Vice-President - Avalere Health, USA Clinical trial design: Alex Kudrin, Independent Consultant, UK Elena Wolff Holz, Chair - EMA Biosimilar Medicines Working Party, UK Niklas Ekman, Vice-Chair - EMA Biosimilar Medicines Working Party Carsten Brockmeyer, CEO - Formycon AG, Germany SESSION 6 - BIOSIMILAR MEDICINES INITIATIVES AT A GLANCE: EMA PERSPECTIVE Moderator: Ildiko Aradi, PhD, Head, Clinical Development of Biologics - Gedeon Richter Hungary and Vice-Chair of the Biosimilars Medicines Group Elena Wolff Holz, Chair - EMA Biosimilar Medicines Working Party Klara Tiitso, Scientific Administrator, Quality - European Medicines Agency (EMA) Sabine Haubenreisser, Principal Scientific Administrator, International Affairs - European Medicines Agency (EMA) Questions and Answers with session speakers P a g e 3

4 13.00 SESSION 7 - INTERNATIONAL REGULATORS UPDATE Moderator: HeeKyung Kim, Senior Vice President/Head of Regulatory Affairs - Samsung Bioepis, South Korea Leah Christl, Associate Director for Therapeutic Biologics - Therapeutic Biologics and Biosimilars Staff, Office of New Drugs, CDER, US Food and Drug Administration (FDA), USA Stephanie Hardy, Manager in the Office of Policy and International Collaboration - Health Canada s Biologics and Genetic Therapies Directorate Claus Bolte, Head of Sector Marketing Authorisation - Swissmedic, Switzerland François-Xavier Lery, Coordinator for Technologies, Standards and Norms - World Health Organization (WHO) NETWORKING BUFFET LUNCH SESSION 8 - ASK YOUR QUESTIONS TO THE INTERNATIONAL REGULATORS Moderator: Cornelia Ulm, Independent Consultant - Biotec Regulatory Consulting GmbH To make the most of this unique occasion, questions should be formulated generally and be sent ASAP to jmarechal@medicinesforeurope.com Leah Christl, US Food & Drug Administration (FDA), USA Stephanie Hardy, Health Canada, Canada Claus Bolte, Swissmedic, Switzerland François-Xavier Lery, World Health Organization (WHO) Niklas Ekman, EMA Biosimilar Medicines Working Party, UK Klara Tiitso, Scientific Administrator, Quality - European Medicines Agency (EMA) CONCLUDING REMARKS AND CLOSURE OF THE CONFERENCE Julie Maréchal-Jamil, Director Biosimilar Policy & Science END OF CONFERENCE COFFEE AND DESSERT FOLLOW THE EVENT ON TWITTER #BIOS18 P a g e 4

5 PLATINUM SPONSOR OTHER SPONSORS MEDIA PARTNERS P a g e 5