Cell and Gene Therapy - From Concept to Clinical Use

Cell and gene therapies are powerful tools against disease, but regulatory steps can delay their development. Understanding the language, testing requirements, and qualifications involved is essential. This webinar defines essential terms, reviews safety and quality testing requirements, explains the importance of supplier and materials qualifications, and provides tips on controlling your processes as you navigate the regulatory landscape.

 

What Will You Learn

  1. Understand the cell and gene therapy regulatory landscape and language
  2. Learn how to plan, advance and adopt a regulatory approach
  3. Learn how to incorporate required safety and quality testing in the product life cycle
  4. Learn about qualifications for suppliers and materials
  5. Get tips on how to control your processes

Consult Our Experts

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Meet Our Experts

Ravid Grimberg

Head of Regulatory Affairs (RA) for the Cell Culture Technologies and Advanced Therapies

Ravid Grimberg joined Sartorius in 2020, where she is head of Quality Assurance (QA) and Regulatory Assurance (RA) for the Advanced Therapies Division. She holds a bachelor’s degree in biology and master’s degree in QA and reliability from The Technion Israel Institute of Technology. Ravid has held varied positions in QA and RA, including Vice President for QA & RA at Biological Industries.

Alan Minsk

Partner at Arnall Golden Gregory, LLP

Alan Minsk is a partner and leader of the Food & Drug practice team at Arnall Golden Gregory, LLP. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, and food (including dietary supplements) companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration. Alan has been recognized frequently by Who’s Who Legal, Best Lawyers, and Chambers USA. Alan currently serves on the editorial boards for the Food and Drug Law Institute’s (FDLI) Food and Drug Law Journaland Regulatory Affairs Professionals Society’s (RAPS) Regulatory Focus publications.