After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
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APPENDIX C<br />
<strong>Pew</strong> Stakeholder Conference<br />
Agenda<br />
Monday, March 14<br />
Day 1: Globalization of Pharmaceutical Manufacturing:<br />
Updating Quality Systems and Oversight<br />
Moderator: William K. Hubbard, Advisor, Alliance for a Stronger FDA<br />
9:00–9:20 a.m. Welcome Remarks<br />
Speaker: Allan Coukell, BScPharm, Director of Medical Programs, <strong>Pew</strong> Health Group<br />
9:20–9:45 a.m. Opening Keynote<br />
Speaker: John M. Taylor III, Esq, Acting Principal Deputy Commissioner, FDA<br />
9:45–10:30 a.m. Q&A<br />
10:45–11:45 a.m. Session 1: Ensuring quality and safety across manufacturing supply chains<br />
11:45–12:20 p.m. Roundtable Discussion<br />
12:20–12:30 p.m. Q&A<br />
Panelists: Martin VanTrieste, Chair, Rx-360, Senior Vice President, Quality, Amgen<br />
Roger L. Williams, MD, CEO, United States Pharmacopeia<br />
Philippe Andre, MScPharm, MA, Director, Qualiau Pharmaceutical Auditing Co.,<br />
Ltd., Associate Professor at the School of Pharmaceutical Science and Technology<br />
at Tianjin University<br />
Key Questions: 1. What steps should manufacturers take to safeguard global supply<br />
chains?<br />
2. How should companies assess suppliers?<br />
3. Are there policy mechanisms that could improve compliance with quality<br />
standards?<br />
4. How can analytical standards and tests be improved?<br />
<strong>After</strong> <strong>Heparin</strong>: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 109
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