Complying with the FDA’s gene and cell therapy regulations — particularly conducting comparability studies — is a huge challenge. But when the smallest changes to processes or analytical methods can derail a product’s approval, it’s time to make sure you’ve covered every detail.
Compliance starts with this webinar: learn to understand and follow the FDA’s requirements and avoid common errors so you can maintain your products’ critical quality attributes (CQA) 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 you need to know about comparability so you can meet all requirements and obtain approvals.
- 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 your opportunity to ensure yours comply.
Who Will Benefit:
- Quality professionals
- Regulatory affairs professionals
- Manufacturing process development professionals
- Analytics professionals
- Research and development personnel
- Senior management at cell and gene therapy (pharma/biotech) companies