Global Regulatory Perspectives Workshop
May 18, 2011
8:00am - 5:00pm
De Doelen Congress Centre
Objectives:
To provide participants with viewpoints and perspectives from international regulators of cell therapy products. Sessions will include presentations and case studies on the following topics:
- Clinical Trials
- Product Approval
- Manufacturing Materials
- Cord Blood Banking
Program:
View the final program here. Slides will be made available on or before Tuesday May 31st. All delegates will receive an email with a link to the presentations. If for any reason you do not receive this email, please contact Audrey Le at audrey@celltherapysociety.org.
Overview:
Session I – Regulatory Considerations for Cell Therapy Clinical Trials
Case Study – Clinical Trials
Session II – Regulatory Considerations for Product Approval
Case Study - Product Approval
Case Study – Materials for Manufacturing
Session III – Regulation of Cord Blood Banking: Global Implications
Case Study – Cord Blood
Organizing Committee:
Chairs:
Scott Burger, MD, Advanced Cell & Gene Therapy - USA
Karen Edward, BSc, MT (ASCP), Advanced Cell & Gene Therapy - USA
Committee Members:
Martino Introna, MD
Head, Laboratory for Cell Therapy, Laboratorio Di Terapia Cellulare E Genica - Italy
William Janssen, PhD
Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center - USA
Karen Nichols, Esq. RAC, VP,
Regulatory and Quality, PerkinElmer, Inc. - USA
Akihiro Shimosaka, PhD
Director, Research and Development Division, Research Foundation for Community Medicine - Japan
Ineke Slaper-Cortenbach, PhD
Director, University Medical Center Utrecht – The Netherlands
Dominic Wall, PhD
Operations Director, Peter MacCallum Cancer Centre - Australia
Supporters
