FALLS CHURCH, Va. (PRWEB)
July 27, 2022
Gene & Cell Therapy Regulation:
Comparability and Other New Developments
An FDAnews Webinar
Wednesday, Aug. 10, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/gene-and-cell-therapy-reg
For drugmakers 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 manufacturers don’t have a handle on the new requirements a minor process change could cause enormous issues with quality and efficacy. And compliance.
This webinar will enable attendees to understand and comply with the FDA’s requirements and avoid common errors, so they can 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:
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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
Understanding and meeting, comparability requirements is crucial to developing gene and cell therapy products. This is an opportunity for drugmakers to ensure theirs comply.
Webinar Details
Gene & Cell Therapy Regulation:
Comparability and Other New Developments
An FDAnews Webinar
Wednesday, Aug. 10, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/gene-and-cell-therapy-reg
Tuition:
$287
Easy Ways to Order:
Online: https://wcg.swoogo.com/gene-and-cell-therapy-reg
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.
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