In this Webinar…

Global access to cell and gene therapy products is crucial for patient care. As such, this webinar serves as a unique roadmap with actionable strategies toward fostering regulatory harmonization worldwide.

The ICH CGT Discussion Group will address regulatory challenges, create a framework for regulatory development, and analyze comparability assessments to ensure the safety, efficacy, and quality of CGT products. This live session explores clinical and non-clinical factors that affect CGT development, and unique strategies for navigating these roadblocks.


Learning Objectives:

1. Identify the status of the ICH Cell and Gene Therapies Discussion Group (CGT DG) and opportunities for harmonization and regulatory reliance.

2. Analyze current requirements for cell and gene product comparability alongside corresponding challenges for therapeutic modality.

3. Discuss unique clinical and non-clinical considerations for cell and gene therapeutic products.

Speakers:

• Lesbeth Rodriguez, MS
  Director, Regulatory Affairs, Policy and Innovation at Bayer

• Mantej (Nimi) Chhina, PhD, JD
  Executive Director, Head of Global R&D and Regulatory Policy at BioMarin Pharmaceutical Inc.

• Nicole Verdun, MD
  Director, Office of Therapeutic Products, CBER
  FDA