Cell and Gene Therapy Clinical Trials’ Regulatory Strategies and Safety Considerations

Watch this on-demand webinar to gain insight and best practices on navigating regulatory communications with the US FDA and managing safety considerations for the efficacy endpoints for cell and gene therapy products.

Discover valuable insights on:

• Successfully navigate the regulatory framework for novel interventional agents
• Understand agency expectations on the adequacy of information to support the conduct of clinical studies
• Effectively manage unique safety considerations such as the timing of initial assessment to long-term follow up
• Address the timing of efficacy endpoints assessment in early-phase vs late-phase clinical trials