Activities

FDAAA International Network co-sponsors 2nd Annual Workshop on Regulatory Science-based Decision Making for China's State FDA's Center for Drug Evaluation on May 20, 2010, Beijing

To further advance the establishment of science-based decision-making process as a foundation for regulatory review decisions in China, the State Food and Drug Administration's (SFDA) Center for Drug Evaluation (CDE) organized, "The 2nd Annual Workshop on Regulatory Science-Based Decision-Making," at Beijing Jiangxi Plaza on May 20, 2010. The event was co-sponsored by State Food and Drug Administration (SFDA)/China Center for Pharmaceutical International Exchange (CCPIE), the FDA Alumni Association International Network (FDAAAIN), and Peking Union Medical Colleague (PUMC). The CDE senior management and entire review staff, along with CCPIE and PUMC members attended the workshop.

Last June 2009, SFDA/CDE and FDAAA held the first annual workshop entitled, "Science-based Regulatory Decision-making – Case-based Approach," focusing on the key challenges and regulatory issues in anti-infective, oncology and vaccine areas. Building on the success of the prior workshop, this 2nd annual workshop continues with the scheme of good science-based regulatory decision making. Dr. Florence Houn (FDAAAIN co-chair), Dr. Mark Goldberger and Dr. Bob Powell delivered three lectures, "Scientific Decision-Making: Foundations", "Benefit-Risk Assessment and the Interpretation of Safety Signals", and "Quantitative Decision Making by Drug Regulators", respectively. Dr. Zili Li (FDAAAIN co-chair) presented an audience-participation discussion based on a real case of a drug with pre- and post-marketing issues. By employing a case-based approach to share with the audience the challenges of regulatory decision making at US FDA, the workshop illustrated the importance of the effective using of data and evidences to ensure the scientific integrity of a regulatory decision.

The SFDA/CDE has a link to the workshop:

http://www.cde.org.cn/newspic.do?method=view&id=311733


Front Row (from left to right):

  • Dr. Chi-Wan CHEN, Executive Director, Pfizer, Inc, Former Deputy Director, Office of New Drug Quality Assessment, FDA/CDER
  • Dr. Jim WEI, Director of Clinical Pharmacology, Medpace, Former Senior Reviewer, Office of Clinical Pharmacology, FDA/CDER/OTS;
  • Mr. Yi FENG, Director, Office of Review Management, SFDA/CDE
  • Dr. Florence HOUN, Vice President, Regulatory Policy and Strategy, Celgene Corporation, Former Director, Office of Drug Evaluation III, FDA/CDER (1999~2006) and Co-chair of FDAAA International Network
  • Dr. Mark J. GOLDBERGER, Divisional Vice President for Regulatory Intelligence and FDA Liaison Issues, Abbott Laboratories; Former Director, Office of Drug Evaluation IV, FDA/CDER (2001~2006)
  • Ms. PeiPei ZHANG, Deputy Director, SFDA/CDE
  • Dr. Zili LI, Emerging Market Regulatory Strategy & Policy Lead, Merck & Co., Inc.; Former Medical Team Leader, Office of New Drugs, FDA/CDER; Co-chair of FDAAA International Network
  • Dr. Bob POWELL, Scientific Advisor, Roche (China) Holding Ltd Shanghai, Former Director, Pharmacometrics, Office of Clinical Pharmacology FDA/CDER;
  • Ms. Jianhong YANG, Deputy Director, Office of Review Management, SFDA/CDE
  • Dr. Yi JIANG, Co-Director, Phase I Unit, PUMC Hospital;

 

2nd Row (from left to right):

  • Dr. John GONG, Vice President and Chief Technology Officer, Joinn Laboratories; Former Toxicology and Pharmacology reviewer, FDA/CDER
  • Dr. Hua ZHENG, Executive Director, Regulatory Affairs, Celgene Corporation and Former Toxicology and Pharmacology reviewer, FDA/CDER
  • Dr. Huan YANG, Senior Clinical Reviewer, Office of Drug Review V, SFDA/CDE
  • Mr. Baoshu WEN, Project Coordinator, Office of Review Management, SFDA/CDE
  • Dr. Pei HU, Co-director Phase I unit, PUMC Hospital
  • Dr. Long CHENG, Clinical Reviewer, Office of Drug Review I, SFDA/CDE
  • Mr. Jifeng SHI, Project Coordinator, Office of Review Management, SFDA/CDE

 

Absent from photo: Dr. Ning LI, Sr. Director, Regulatory and Medical Policy, Sanofi-Aventis China, Former Statistical Team Leader, FDA/CDER.