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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
European Commission, DG Health & Food Safety, Belgium
Director
Emer Cooke, MBA, MSc
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President
New EU Pharma Legislation - Implementation Ahead?
Sabine Atzor, MPharm, RPh
F. Hoffmann-La Roche Ltd, Switzerland
Head of EU Regulatory Policies
Christine Kampf, MS
Marinus Pharma, United States
Executive Director of Regulatory Affairs
Niklas Hedberg, MPharm
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTACG Co-Chair & Chief Pharmacist
Nikos Dedes
European AIDS Treatment Group (EATG), Greece
Representative
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