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Square Brussels Convention Centre

Mar 12, 2024 9:00 AM - Mar 14, 2024 4:00 PM

Glass Entrance, Mont des Arts/Kunstberg, 1000 Brussels, Belgium

DIA Europe 2024

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

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

Rainer Becker

European Commission, DG Health & Food Safety, Belgium

Director

Emer  Cooke, MBA, MSc

Emer Cooke, MBA, MSc

European Medicines Agency, Netherlands

Chair, ICMRA; Executive Director

Karl  Broich, DrMed

Karl Broich, DrMed

Federal Institute for Drugs and Medical Devices (BfArM), Germany

President

Sabine  Atzor, MPharm, RPh

New EU Pharma Legislation - Implementation Ahead?

Sabine Atzor, MPharm, RPh

F. Hoffmann-La Roche Ltd, Switzerland

Head of EU Regulatory Policies

Christine  Kampf, MS

Christine Kampf, MS

Marinus Pharma, United States

Executive Director of Regulatory Affairs

Niklas  Hedberg, MPharm

Niklas Hedberg, MPharm

Dental and Pharmaceutical Benefits Agency, TLV, Sweden

HTACG Co-Chair & Chief Pharmacist

Nikos  Dedes

Nikos Dedes

European AIDS Treatment Group (EATG), Greece

Representative

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