Skip to main content
RAPS Euro Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event
Evaluation

Pharmaceuticals

Combined Studies: Interface Between the Regulations on Clinical Trials of Medicinal Products, Medical Devices and in vitro Diagnostics (Current Situation and Future Regulatory Framework)

Thursday, May 15, 2025
14:30 - 15:30 CEST
Location: Gold Hall (level 0)
Learning Level: Intermediate
Description: The EU regulatory landscape for combined studies involving medicinal products, medical devices, and in vitro diagnostics is complex and continually evolving. This session will delve into the current situation and future regulatory frameworks, providing participants with a comprehensive understanding of the interface between these regulations.
Participants will gain insights into the latest regulatory updates and their implications for clinical trials in the EU. The session will cover key topics such as the integration of regulatory requirements, challenges in conducting combined studies, and strategies for compliance. Additionally, we will discuss the role of regulatory bodies and the impact of new regulations on the development and approval of combined products.

Join us to learn from experts from industry and EMA and gain practical knowledge that will help you manage the complexities of combined studies and stay ahead in the ever-changing regulatory environment.

Learning Objectives:

  • Understand the current EU regulatory landscape for combined studies involving medicinal products, medical devices, and in vitro diagnostics.
  • Gain insights into future regulatory frameworks and their implications for clinical trials in the EU.
  • Learn best practices for navigating the interface between different regulatory requirements