WCG FDAnews
FALLS CHURCH, Va. (PRWEB) February 07, 2022
Gene & Cell Therapy Regulation:
Comparability and Other New Developments
An FDAnews Webinar
Thursday, Feb. 17, 2022, 1:30 p.m.–3:00 p.m. EST
https://wcg.swoogo.com/gene-and-cell-therapy-regulation
If a company is involved in developing gene and cell therapy products, the FDA and other regulators have made it clear: comparability studies are essential to product approval. But if one doesn’t have a handle on the new requirements … the minor process changes could cause enormous issues with quality and efficacy. And compliance.
This webinar will enable one to understand and comply with the FDA’s requirements and avoid common errors, so the company can maintain a 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 one needs 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
Understanding — and meeting — comparability requirements is crucial to developing gene and cell therapy products. This is the opportunity to ensure compliance.
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
Webinar Details:
Gene & Cell Therapy Regulation:
Comparability and Other New Developments
An FDAnews Webinar
Thursday, Feb. 17, 2022, 1:30 p.m.–3:00 p.m. EST
https://wcg.swoogo.com/gene-and-cell-therapy-regulation
Tuition:
$297 per site
Easy Ways to Register:
Online: https://wcg.swoogo.com/gene-and-cell-therapy-regulation
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
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 FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations