Regulatory Review Process of New Medicines in China

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Thursday, October 25th, 12:30-1:55pm

The rapid development of the Chinese pharmaceutical industry is presenting new opportunities for new medicine commercialization. Positive steps have been made towards drug registration standardization and the necessary levels of administrative investment. How can both Western and Chinese companies take advantage of China’s review process to create mutually beneficial outcomes for patients and industry? How can the SFDA communicate with companies to improve the review process?

Moderator:

  • Shaoyu Chen, Partner, Covington & Burling LLP

Panelists:

  • Wassim Nashabeh, PhD, Global Head, Technical Regulatory Policy & Strategy, Genentech, Inc.
  • Romi Singh, Executive Director, Global Regulatory Affairs & Safety, Amgen
  • Chang Weihong, Division Chief, Drug Registration, State Food and Drug Administration (SFDA)
  • Wendy Yu, Director, Regulatory Affairs China, MSD R&D (China) Ltd.

Who's Who

Shaoyu Chen
Partner, Covington & Burling LLP

Shaoyu Chen is a member of Covington’s Food and Drug practice group and the managing director of its China food and drug practice.  Mr. Chen has over 10 years of experience in food and drug law, including serving as assistant chief counsel at the United States Food and Drug Administration Office of Chief Counsel, as senior counsel at Amgen Inc., and as chief compliance counsel for GE Healthcare China.  Mr. Chen represents pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic companies in matters before the China SFDA, the U.S. FDA, and other government agencies.  He regularly assists clients on legal and regulatory issues related to SFDA and FDA oversight, including those pertaining to preclinical research, clinical trial, marketing approval, advertising and promotion, manufacturing GMP, pharmacovigilance, import and export, and compliance with Foreign Corrupt Practices Act and China Anti-Unfair Competition Law.

 

Wassim Nashabeh, PhD
Global Head, Technical Regulatory Policy & Strategy, Genentech, Inc.

Dr Wassim Nashabeh received his PhD in Analytical Chemistry from Oklahoma State University in 1993, and his post-doctoral fellowship from “Barnett Institute of Chemical and Biological Analysis” at Northeastern University where he developed new approaches for the separation of closely related recombinant protein variants.  Thereafter, he joined PerSeptive Biosystems as a Senior Scientist from 1994-1996, where he co-developed new schemes for antibody modification with fluorescent and enzymatic labels for use in micro-fabricated chips based immunoassays.

In 1996, Dr Wassim Nashabeh joined Genentech (A member of the Roche Group) as a Scientist and had since held several positions of increasing responsibilities including Associate Director, Methods validation group, Director Quality Control Clinical Development, Director in the CMC Regulatory Affairs Group, Sr. Director of CMC Policy & Strategy and most recently as Global Head, Technical Regulatory Policy & Strategy for the Roche Pharma Medicines Group. His current primary responsibilities include the development of global innovative regulatory strategies, as well as the development of key positions on a variety of subjects of significant impact to Pharma Technical Operations. Dr Nashabeh chairs the Pharma Technical External Interactions Steering Committee with responsibility for the oversight of all external outreach activities with global health authorities, industry associations and scientific organizations on technical matters.

Dr Nashabeh is the author/co-author of over 30 scientific publications, reviews and patents in the field of separation science and biotechnology. Wassim is a member of the Expert Working Group for the International Committee on Harmonization representing the BIO organization on Quality topics (currently Q11 and Q3D).  Wassim is also a member of the Board of Directors of CASSS (an International Separation Science Society), co-founder and chair of the “International Symposium of CE in the pharmaceutical and Biotechnology Industries”, a permanent committee member of the CMC strategy forum conference series, co-founder of the CMC Forum Europe Conference Series as well as a member of the program committee for the WCBP conference series. Dr Nashabeh has co-chaired several biotechnology forums and events that focused on a variety of CMC related issues over the last 10 years including “Lifecycle approach of Setting Product Specifications”, “Changing paradigms for process validation”, “Design of Stability Studies”, “Quality by Design for Biotechnology Products” and “Comparability for Biotech Products”.

 

Chang Weihong
Division Chief, Drug Registration, State Food and Drug Administration (SFDA)

Ms. Chang has been serving as the Deputy Director of the Biological Products Division of the Drug Registration Department of the SFDA for 2 years. Over the course of her career, Ms. Chang has been involved in a number of vaccine and diagnostics evaluations and has participated in the drafting of many biological products registration regulations and technology guidelines.

Previously, she worked at the SFDA Center for Drug Evaluation for 10 years, where she served in numerous positions, including Director of Biological Products, Program Head, and Chief Reviewer, among others.

Ms. Chang graduated from Peking University in 1990 with a major in Biology.