EMA vs FDA Perspective on Regulatory Challenges: Evaluation & Implementation of Innovative Technologies in Innate Cell Therapy
Time: 9:00 am
day: Pre-Conference Day
Details:
Innovation in the innate cell therapy space is moving fast to help generate a potent, safe and persistent innate cell therapy for a variety of indications both within and outside oncology. New tools and approaches emerge to address the challenges of cell quality, scalability, delivery and supply with a view to achieving more accessible and affordable
therapies.
The regulatory framework and quality requirements applicable to cell therapies, including products used in immuno-oncology are entering an age of standardisation. Drug developers require global regulatory clarity for these state-of-the-art strategies to bring efficacious therapies to patients faster. In return, the industry should be proactive and support the establishment of these crucial regulatory standards.
Join this workshop for insights into:
- Innate cell specific regulatory considerations for potency assay development
- Donor source safety requirements to promote a successful allogeneic strategy
- The CMC requirements and challenges in the development of innate cell therapies both in the US and in the EU
- Key constraints in developing and implementing new processes using IPSC derived cell therapies as an example
- Regulatory requirements for successful implementation of manufacturing changes
- FDA and EMA alignment and perspective on key regulatory issues to build clarity for the global innate cell therapy community
