We are excited to invite you to join EUCOPE during its two panel sessions during the largest global event for the biotech & life sciences industry.

Monday, 5 June | 13:00 – 14:00 ET (Room 209)

PANEL – The New European Pharmaceutical Landscape: What you need to know when launching in the EU

The EU pharmaceutical landscape is experiencing its most significant transformation in over 20 years and signals a fundamental shift in thinking. The EU is revising the regulatory and incentive systems for all medicines, including orphan products. The imminent application of the EU HTA Procedure means there will be a new mandatory system for assessing the clinical value of new products for the European market, starting with cancer therapies and Advanced Therapy Medicinal Products (ATMPs) in 2025, Orphan drugs will come into effect in 2028 and all products approved by the EMA will follow in 2030.

The full EU pharmaceutical ecosystem is being updated in the coming decade and this session will explore the essentials you need to consider before launching your product in the EU.

Panelists:

• Dr. Steffen Thirstrup, Chief Medical Officer, European Medicines Agency (EMA)
• Alexander Natz, Secretary General, EUCOPE – European Confederation of Pharmaceutical Entrepreneurs
• Nicholas Cosenza, Sr. Manager – Government Affairs, Amgen
• Thomas Bols, Director of Government Affairs and Patient Advocacy, PTC Therapeutics
• Maya Matthews, DG SANTE (TBC)

Moderator: Matias Olsen, Public Affairs & Policy Manager, EUCOPE

Monday, 5 June | 13:00 – 14:00 ET

ROUNDTABLE – EU Pharmaceutical Environment Crash-Course

The European Pharmaceutical landscape is becoming more complicated. This session will drill deeper into the key themes presented at the New European Pharmaceutical Landscape: What you need to know when launching in the EU panel and aims to address any questions you might have on the review of the EU Pharmaceutical Legislation and the implementation of the EU HTA Regulation. This is a great opportunity to speak with EU experts and expand your knowledge so that you can step into the EU with open eyes. As a regulatory trendsetter, developments in the EU may also shape discussions in other world regions, so this is your chance to get ahead of the curve.

Participants:

• John A. Murphy, III., Chief Policy Officer Deputy Counsel, Healthcare, Biotechnology Innovation Organization (BIO)
• Alexander Natz, EUCOPE
• Claire Skentelbury, Secretary General, EuropaBio
• Victor Maertens, Government Affairs Director, EUCOPE
• Matias Olsen, EUCOPE

Register for #BIO2023 here.