概要

This webinar will provide an overview of the Plausible Mechanism Framework and its role in supporting the development of advanced therapies. Through expert presentations and an interactive Q&A, attendees will explore the framework’s scientific and regulatory foundations, the use of prior knowledge in regulatory decision-making, and key policy considerations for its application to cell and gene therapies.

特集トピック

Understanding the framework and its role in advancing cell and gene therapies
Exploring the evidence base and regulatory principles that support the framework
Key opportunities, challenges, and considerations for implementing the framework

参加対象

Who should attend: The webinar is designed for Biopharmaceutical and biotechnology professionals, Regulatory affairs professionals, Clinical and translational researchers, CMC, nonclinical, and clinical development teams, Policy and government affairs professionals.

学習目的

By the end of this webinar, participants will be able to:
- Explore the purpose, principles, and potential impact of the framework in advancing innovative therapeutic development.
- Learn how existing scientific evidence and prior knowledge can inform regulatory assessment and approvals.
- Examine key policy issues and implementation challenges related to cell and gene therapy development.

参加申し込み

DIA Direct: Unlocking the Plausible Mechanism Framework: Advancing Innovation in Cell and Gene Therapies

概要

特集トピック

参加対象

学習目的

最新情報や機会を逃さないで