Case Study: Convening on Regulations to Establish Frameworks and Best Practices for the Industry

Time: 11:00 am
day: Day One


This deep-dive will be a series of presentations, roundtables, and problem-solving group activities to provide a framework of experience with regulatory filings in Europe and South America, and to discuss key questions for the field with the session leaders to help guide your own regulatory journey.
• Communicating processes and aligning with regulatory requirements and achieving compliance with SOPs and controls
• Discussing the published guidance on process development for cell therapies
• Highlighting the gaps in how generalized regulations apply to process development
• Generating supporting documentation in process development to justify changes from PD to QC
• Highlighting the different experiences in Europe and the US with materials, quality and process requirements
• Managing the evolving regulatory environment alongside product heterogeneity and developing assays and processes to enable flexibility