Navigating the EU regulatory landscape: Accelerating drug development, treatment innovation and market access

Webinar series on demand

The EU legislative framework is undergoing a period of substantial change to react to a seismic shift in scientific and technological advancements. During this three-part webinar series, we cover key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions.

The future of decentralized clinical trials in an evolving EU regulatory landscape


This webinar addresses the critical importance of the following:

  • A robust and secure technology architecture for trial related data acquisition, storage, and communication
  • A drug distribution and management strategy that meets all stability, storage, and dosing access and administration requirements
  • A high-level understanding of the evolving EU regulatory landscape to ensure compliance with good clinical practice (GCP) requirements and all relevant legislation

Entering first-in-human clinical trials: A five point strategy for building a robust CMC dossier

This webinar discusses the five strategies to build a robust CMC package, help streamline the path to FIH trials for biologics and establish the quality foundation needed to support all of the development phases toward commercialization including :

  • Regulatory CMC in early development teams
  • Keeping patient and clinical experience in mind
  • Building a phase-appropriate dossier
  • Considering and conveying the basis for the strategy
  • Obtaining regulatory advice at every opportunity

Flexible regulatory pathways and key CMC considerations to commercialize cell and gene therapy products

This webinar provides key advice for determining and navigating the regulatory pathway for any cell and gene therapy, including the following:

  • Early, proactive engagement with the established regulatory authorities that specialize in the evaluation of cell and gene therapies
  • The key components of programs to accelerate application review within major regulatory jurisdictions
  • Critical considerations for site selection and CMC development of viral vectors for cell and gene therapies