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Summary of FDAAA International Network Pilot Educational Workshop

June 16, 2009 FDAAA Regulatory Science Educational Workshop in Beijing, China

On June 16, 2009, the Food and Drug Administration Alumni Association's International Network (FDAAA IN) co-sponsored a successful pilot regulatory science educational seminar with the Center for Drug Evaluation/State Food and Drug Administration (CDE/SFDA), and the China Center for Pharmaceutical International Exchange/State Food and Drug Administration (CCPIE/SFDA) for CDE personnel. The Workshop on Science-based Regulatory Decision-making: A Case-Study Based Approach educational was a day long event. The morning consisted of lectures utilizing case examples presented by three FDAAA members who were former FDA Office Directors. The afternoon consisted of in-depth small group discussions with the FDAAA lecturers and CDE review staff, facilitated by bi-lingual FDAAA members. The three lectures and group discussion topics were:

1. Vaccine Development Issues by Florence Houn (co-chair, FDAAA IN)
2. Science-based Decision-making for Anti-Infective Products by Mark J. Goldberger
3. New Treatment for Cancer: US Regulatory Considerations by Robert J. DeLap

FDA Alumni Zili Li (co-chair, FDAAA IN), Jim (Xiaoxiong) Wei, John (Zhaolong) Gong, and Hua Zheng facilitated discussion and translation.

On June 18, 2009, the CDE/SFDA placed a story regarding the workshop on their website: http://www.cde.org.cn/news.do?method=largeInfo&id=311262 See below for translation and photo identification.

This inaugural FDAAA IN educational activity was very successful. The FDAAA IN will continue to explore ways to do outreach and provide education to regulatory health authorities regarding establishment and operations of regulatory programs.

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Translation of the CDE web site:

On June 16th, a "workshop of science-based regulatory decision-making" was held at CDE. This workshop was organized by CDE and co-organized by SFDA-CCPIE and FDAAA; the topics were based on FDA previous review cases. In this workshop, three former review office directors of FDA review centers were invited: Drs. Florence Houn, Mark J. Goldberger, and Robert J. DeLap. They were Directors of offices of vaccines, anti-inflammatory drug products and oncology drug products at CBER and CDER, respectively.

The workshop had two sessions: the presentations and the breakout discussions. The three experts presented major topics: "Vaccine Development Issues", "Science-based regulatory decision - Review of anti-inflammatory Drug products", and "New Treatment for Cancer- US Regulatory Considerations". Three breakout groups, comprised of reviewers of CDE, discussed around the respective indications, focused on the strategy, considerations and specific issues encountered in drug review. The vaccine group had also invited R&D staffs from Kexing Biotec Ltd. and Hualan Biotec, Ltd.

This event was supported by Drs. Zili Li, Xiaoxiong Wei, Zhaolong Gong and Hua Zheng from FDAAA; their contribution is greatly appreciated."

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