FALLS CHURCH, Va. (PRWEB)
July 08, 2020

Overcoming Comparability Issues in Regenerative Medicines Manufacturing:

The Latest on Cell and Gene Therapy Regulation

An FDAnews Webinar

Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/cellandgenetherapy

A product may need a comparability study, but what is the most effective way to complete one? Will the study comply with all FDA requirements? Understanding how to meet the expectations of this task is critical for anyone creating and manufacturing these therapies.

While the natural evolutions of a therapy may have improved it, the shifts risk its critical quality attributes, or CQAs. Comparability studies mitigate those risks and allow one to retain those CQAs. An effective study will match the level of changes, with stricter comparability needed as greater adjustments accumulate.

During this FDAnews webinar, attendees will learn the most effective ways to navigate the process and meet FDA expectations. Scott R. Burger, MD and principal of Advanced Cell and Gene Therapy, will share practical tips and guidelines around determining the level of a comparability study, planning and preparing for an analysis, and avoiding common mistakes before FDA interactions:

• 
  FDA Requirements for Comparability Studies

     a. Assembling the best comparability package

• Risk Analysis and Mitigation

     a. Best practices around comparability study risks

     b. Determining the necessary rigor of a comparability study

• Designing an Effective Comparability Protocol

     a. Using the right analytical tools, samples, and statistical analyses

     b. In vitro versus in vivo comparability studies

     c. Understand common mistakes and how to avoid them

• Statistical Comparability Approaches

Managing comparability studies to achieve approval for cell and gene therapy products is a complicated but necessary process. Ensure products retain their CQAs and meet all FDA requirements.

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:

Overcoming Comparability Issues in Regenerative Medicines Manufacturing:

The Latest on Cell and Gene Therapy Regulation

An FDAnews Webinar

Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/cellandgenetherapy

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/cellandgenetherapy

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

Share article on social media or email: