Clinical trials: Navigating legal and regulatory pitfalls

At this seminar, our legal specialists will share practical insights into key regulatory and data protection issues that should be addressed before a clinical trial begins. 

Drawing on our advisory experience, we will explore common pitfalls, recent developments, and strategies for ensuring legal readiness in clinical trial planning.

Preliminary Program

13:00: Welcome and introduction

13:15: Session 1 - Roles and responsibilities in clinical trials

• Managing roles and responsibilities in multicenter trials 
• Understanding key regulatory roles under data protection and clinical trial frameworks
• Assigning responsibilities among Sponsors, Contract Research Organisations, Investigators, and Sites

14:00: Break

14:15: Session 2 - Data protection considerations

• Interplay between Clinical Trials Regulation and General Data Protection Regulation 
• Establishing a valid legal basis for both primary and secondary use of personal data
• The role of research ethics committees 

15:00: Break

15:15: Session 3 - Contracting practices and common deviations

• Identifying and addressing common legal challenges in clinical trial contracts
• Key legal aspects in co-sponsorship contracts 
• Navigating data sharing and regulatory transparency requirements

16:00: Networking / light refreshments

Speakers

• Attorney-at-Law, Partner Bodil Maria Hald
• Attorney-at-Law, Director Mette-Marie Henrichsen
• EU Lawyer, Manager David van Boven
• Attorney-at-Law Rasmus Viktor Refsing Nielsen
• Assistant Attorney Julie Sneholt