Global Regulatory Perspectives (GRP) Pre-Conference Workshop
Date: June 5, 2012
Time: 8:00am - 5:30pm
Registration Fee: Registration for the GRP Workshop is separate from the Annual Meeting. See rates here.
Objectives:
To provide participants with viewpoints and perspectives from international regulators of cell therapy products, and to discuss current questions and regulatory controversies with regulators and industry representatives. This one-day conference will include four sessions of presentations and case studies addressing regulatory considerations for product approval and for marketed products, compliance activities around the globe, and international implications of cord blood banking regulations. The case studies are intended to be interactive and to stimulate lively discussion from the speakers and session participants.
Program Outline:
Session I: Regulations in Emerging Markets
Session II: Regulatory Considerations: Product Approval and Marketed Products
- Case Study - Product Approval
Session III: Materials Standardization and Qualification
- Case Study - Compliance
Session IV: Cord Blood Banking Regulations: International Implications
- Case Study – Cord Blood
Case Studies
The case studies are hypothetical, but are intended to spark discussion of very real questions and concerns. For each case study an industry speaker with relevant expertise will present their hypothetical answer to the issues raised by each case, and similarly an international medicinal regulator or inspector will respond. An international panel with members from leading medicinal regulatory agencies will also contribute with their views on expectations for importers and local manufacturers. Vigorous and robust discussion will be encouraged with the audience so that attendees can obtain an insight on managing these ‘worst case’ situations.
GRP Organizing Committee:
Chairs:
Scott Burger, MD, Advanced Cell & Gene Therapy - USA
Karen Edward, BSc, MT (ASCP), Advanced Cell & Gene Therapy - USA
Committee Members:
Kurt Gunter, MD, Global Medical Director, Hospira Inc. - USA
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
Dominic Wall, PhD, Operations Director, Peter MacCallum Cancer Centre - Australia
Paula Salmikangas, PhD, Vice-Chair CAT - Finland
