WCG FDAnews Announces: Gene & Cell Therapy Regulation Webinar on December 14, 2022

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For drug makers involved in developing gene and cell therapy products, the FDA and other regulators have made it clear: comparability studies are essential to product approval. It is critical that drug makers understand these new requirements in order to avoid minor process changes that could result in quality, efficacy or compliance challenges.

This webinar will enable attendees to understand and comply with the FDA’s cell and gene therapy requirements and avoid common errors that can result in quality, efficacy, or compliance challenges. It is critical for drug makers maintain their products’ critical quality attributes (CQAs) and bring them to market.

Scott R. Burger, MD, the principal of Advanced Cell & Gene Therapy, and William E. Janssen, PhD, the principal of WEJ Cell and Gene Therapy Consulting Services, will explain exactly what attendees need to know about comparability, including:

  • FDA requirements for comparability studies for gene and cell therapy products
  • Best practices for risk analysis and mitigation using comparability studies
  • How to design an effective comparability protocol for a gene or cell therapy product
  • How to construct a statistical approach to comparability
  • How to assemble the comparability package to comply with FDA requirements
  • An update on FDA regulatory announcements that include forming a consortium to deal with rare diseases and potential guidance about intermediate pathways

Webinar Details
Gene & Cell Therapy Regulation:
Comparability and Other New Developments
An FDAnews Webinar
Wednesday, December 14, 2022, 1:30 p.m.–3:00 p.m. EST


Easy Ways to Order:
Online: https://wcg.swoogo.com/gene-t-cell-therapy-regulation
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.

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Michelle Butler
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