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

Shaping the Future of mRNA Vaccines: A Regulatory Perspective

Friday, May 16, 2025
10:30 - 11:30 CEST
Location: The Arc (level 3)
Learning Level: Advanced
Description: The rapid development and deployment of mRNA vaccines during the COVID-19 pandemic highlighted both the potential and the regulatory challenges associated with this groundbreaking technology. As the landscape of mRNA vaccines continues to evolve, regulatory professionals are at the forefront of shaping policies and frameworks that will guide the future of these innovations.

This session will provide an in-depth exploration of the regulatory considerations specific to mRNA vaccines and biologics, focusing on the unique challenges of safety, efficacy, and manufacturing consistency. Participants will gain a comprehensive understanding of the current regulatory environment, including recent guidance from global health authorities and the strategic approaches necessary to navigate the complex approval processes.

Learning Objectives:

  • Participants will be able to describe the current regulatory landscape for mRNA vaccines, including key guidelines and requirements from global health authorities.
  • Participants will be able to demonstrate how to apply risk-based approaches to regulatory submissions and post-approval changes for mRNA vaccines, ensuring compliance and minimizing delays.
  • Participants will be able to identify strategies to leverage regulatory pathways and incentives to accelerate market access for mRNA vaccines while maintaining safety and efficacy standards.