After Heparin: - The Pew Charitable Trusts

Pew Stakeholder Conference Agenda
1:30–2:30 p.m. Session 2: Ensuring sufficient regulatory oversight of foreign manufacturers
Panelists: Marcia G. Crosse, PhD, Director, Health Care, U.S. Government Accountability
Office
Brant Zell, MBA, Past Chair, Bulk Pharmaceuticals Task Force of the Society
of Chemical Manufacturers and Affiliates; Vice President, Quality, Polypeptide
Laboratories
Guy Villax, Board Member of the European Fine Chemicals Group and of Rx-360;
CEO, Hovione
2:30–3:05 p.m. Roundtable Discussion
Key Questions: 1. How frequently should the FDA inspect foreign plants?
2. Is there a role for third-party inspections?
3. What would constitute an effective system for tracking foreign
manufacturing sites? How can tracking systems integrate with risk
assessment and Customs activity?
3:05–3:15 p.m. Q&A
3:30–4:30 p.m. Session 3: Ensuring a robust regulatory system
Panelists: Heather Bresch, MBA, President, Mylan Inc.
Prabir Basu, PhD, Executive Director, National Institute for Pharmaceutical
Technology and Education
Deborah M. Autor, Esq, Director, Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration
4:30–5:05 p.m. Roundtable Discussion
Key Questions: 1. How should the FDA oversight of foreign plants be funded?
2. Does the FDA need new tools to oversee global supply chains?
3. Are international harmonization and reciprocal recognition of inspections
part of the solution?
5:05–5:15 p.m. Q&A
5:15–5:25 p.m. Concluding Remarks Allan Coukell, Pew Health Group
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Pew Health Group