WELCOME


RENAISSANCE BRUSSELS HOTEL|Rue du Parnasse 19, 1000 Brussels

AGENDA

Thursday, February 8, 2024

 

08:30 – 09:20
 

REGISTRATION AND NETWORKING BREAKFAST
 

09:20 – 09:30
 

WELCOME REMARKS

Conference Co-Chairs

Dr. Alexander Natz, Director-General, EUCOPE

Maarten Meulenbelt, Partner, Sidley
 
 

09:30 – 10:30
 

FUTURE-PROOFING PHARMACEUTICAL LAW

KEYNOTE SPEAKER

Dr. Scott Gottlieb, Former Commissioner, U.S. Food and Drug Administration

RESPONSES

Dr. David Ebsworth, Chairman of the Supervisory Board, Synlab AG, Chairman, Verona Pharma, and Chairman of the Board, Actimed Therapeutics

Hilary Jones, Vice President, Legal Commercial and Pharmaceutical Regulation, BioNTech

Scott Bass, Partner and Founder of Sidley's Global Life Sciences and Food and Drug Law practices in the United States, China, and Europe (Session Chair)
 
 

10:30 – 11:15
 

THE PHARMA REVIEW: REPORT FROM THE FRONT LINES

Representatives of EFPIA and EUCOPE will discuss the negotiations on the Pharma Review taking place that same week in Strasbourg.

Dr. Alexander Natz, Director-General, EUCOPE

Anthony Rodiadis, Policy Officer, DG SANTE, European Commission

Roberta Savli, Executive Director for Public Affairs, EFPIA

SESSION CHAIR: Maarten Meulenbelt, Partner, Sidley
 

11:15 – 11:45
 

COFFEE BREAK
 

11:45 – 12:30
 

HOT TOPICS IN CJEU LITIGATION

COMMENTS: Vincenzo Salvatore, Former Head of Legal Service, European Medicines Agency, and Of Counsel, BonelliErede

SESSION CHAIR: Marie Manley, Partner, Sidley
 

12:30 – 14:15
 

NETWORKING LUNCH
 

14:15 – 15:00
 

IMPLEMENTING THE EU HTA REGULATION

Thorsten Olski, Scientific Officer, Scientific Advice Office, EMA

Stephanie Said, Chair HTA subgroup on Joint Scientific Consultations (JSC), Federal Joint Committee/Gemeinsamer Bundesausschuss (G-BA), Germany

SESSION CHAIR: Mathias Olsen, Senior Manager, Public Affairs and Policy, EUCOPE
 
 

15:00 – 15:45
 

EU COMPETITION POLICY AND ENFORCEMENT TRENDS FOR 2024

Niels van Nuland, Senior Legal Director, Gilead Sciences Pharmaceutical

Blaž Višnar, Deputy Head of Unit, DG COMP, European Commission

SESSION CHAIR: Anne Robert, Partner, Sidley
 

15:45 – 16:15
 

COFFEE BREAK
 

16:15 – 17:00
 

EUROPEAN HEALTH DATA SPACE REGULATION – THE STATE OF PLAY 

Jerome de Barros, Policy Officer, DG Digital Health, European Commission

Meni Styliadou, VP Health Data Partnerships, Data Science Institute, Takeda, R&D Founder and Co-Lead of H2O Enterprise

Verena Thaler, Manager Digital Health, MedTech Europe

SESSION CHAIR: Leander Vranken, Digital Health Policy Officer, EUCOPE
 
 

17:00
 

CLOSING REMARKS
 

 
 

NETWORKING DRINKS