The objective of this workshop is to provide participants with viewpoints and perspectives from international regulators of cell therapy products. Sessions will address:
- New and evolving regulations worldwide.
- Status of compliance activities around the globe.
- Regulatory considerations for multi-national clinical trial design and execution, and current questions and regulatory controversies.
- Case studies will cover current questions and regulatory controversies and will include panelists comprised of regulators and industry representatives.
Sessions include:
- SESSION I: Global Regulatory Update
- SESSION II: Compliance Activities
- SESSION III: Regulatory Considerations for Multi-National Clinical Trials
- SESSION IV: Case Studies
Speakers will include:
- Japan PMDA
- Korea KFDA
- Singapore HSA
- Taiwan FDA
- Australia TGA
- Europe AFSSAPS
- Europe EMEA
- United States FDA
Please click here to view the preliminary program
Registration Fees
Pre-registration is now closed. Registration will re-open on site on Saturday May 22.
| |
Regular Rate
(April 16 until May 14, and on-site) |
| Member |
$240 USD |
| Non-Member |
$290 USD |
Supported by unrestricted educational grants from:
DCI Biotech
Advanced Cell & Gene Therapy
|
