Preparing for AI: Anticipating Regulatory Challenges
Wednesday, May 29, 2024 01:00 PM - 02:00 PM
Room 208-209
Roundtable
Organized by: ISCT Europe Regional Executive Committee & ISCT Lab Practices Committee
Moderators:
Understand how regulation can enable or restrict the transformative potential of AI for biomanufacturing
Key Learning Objectives
1. Understanding the landscape of AI applications in quality management for CGT facilities and their regulatory implications
2. Understanding challenges, opportunities, and best practices in implementing AI-driven solutions for CGT in clinical development and regulatory decision making
3. Discussing regulatory concerns around AI, including different approaches of regulatory bodies and the future trends in CGT
Moderators:
- Simona Stankeviciute, MD, Parexel International, Lithuania
- Wanxing Cui, MD, PhD, CABP(H), Cell Therapy Manufacturing Facility MedStar Georgetown University Hospital, United States
- Mark James Thompson, PhD, Health Research Institute, Faculty of Public Health, Lithuanian University of Health Sciences, Lithuania
- Pille Säälik, PhD, Estonian State Agency of Medicines (SAM), Estonia
- Stephan Kadauke, MD, PhD, Cell and Gene Therapy Lab Children’s Hospital of Philadelphia, United States
Understand how regulation can enable or restrict the transformative potential of AI for biomanufacturing
Key Learning Objectives
1. Understanding the landscape of AI applications in quality management for CGT facilities and their regulatory implications
2. Understanding challenges, opportunities, and best practices in implementing AI-driven solutions for CGT in clinical development and regulatory decision making
3. Discussing regulatory concerns around AI, including different approaches of regulatory bodies and the future trends in CGT
Stephan Kadauke
Assistant Professor or Clinical Pathology and Lab Medicine
Children's Hospital of Philadelphia
Panelist
Assistant Professor or Clinical Pathology and Lab Medicine
Children's Hospital of Philadelphia
Panelist