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EU Regulatory Townhall: The New Pharmaceutical Legislation – How Are We Setting the Stage for Availability and Access of Novel Healthcare Solutions?
Session Chair(s)
Steffen Thirstrup, MD, PHD
Chief Medical Officer, European Medicines Agency, Netherlands
The New Pharmaceutical legislation sets out ways to increase availability, access and affordability of medicines (“triple A”). The European Medicines Agency is already actively implementing the Regulatory Science Strategy and European Medicines Regulatory Network Strategy to 2025 and beyond. These strategies address the triple A challenge, with increased dialogue with patients and healthcare professionals, HTA and payers, as well as embracing new technologies, influencing and facilitating development of highly innovative medicines and treatment. Hear from the European Commission, European Medicines Agency, HMA, patient representatives, pharmaceutical industry and HTA. Are regulators on the right track with the strategies they have set out to enable access and availability of medicines? Share your views on opportunities arising from current significant changes in the European ecosystem and anticipating the impact of the “triple A” political objectives in the new pharma legislation. Debate with us what success looks like in delivering on those!
Learning Objective : - understand legal process and parallel activities - understand implications of the legal changes on EMA and the regulatory system for centrally authorised medicines
Speaker(s)
Rainer Becker
Director, European Commission, DG Health & Food Safety, Belgium
Emer Cooke, MBA, MSC
Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Karl Broich, DrMed
President, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Sabine Atzor, MPHARM, RPH
Head of EU Regulatory Policies, F. Hoffmann-La Roche Ltd, Switzerland
New EU Pharma Legislation - Implementation Ahead?
Christine Kampf, MS
Executive Director of Regulatory Affairs, Marinus Pharma, United States
Niklas Hedberg, MPHARM
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Nikos Dedes
Representative, European AIDS Treatment Group (EATG), Greece
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