FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China

By Zili Li, Nancy Myers and Jinjie Hu

Built on the success of FDAAA International Network’s collaboration with DIA China and its educational effort in China for the past four years, FDAAA IN sent a largest delegation this year to the 7th DIA China annual conference in Shanghai China (May 25-27) led by Ms. Nancy Myers, Chair of FDAAA board of directors and Dr. Jinjie Hu, Co-chair of FDAAA International Network.

FDAAA’s participation has significantly contributed to the success and quality of the plenary sessions at the first day of the conference:

• Dr. Zili Li, former FDAAA IN co-chair, delivered welcome address as the co-chair of this year’s DIA Annual conference.
• Dr. Peggy Hamburg, Former Commissioner of US FDA and FDAAA member, delivered the keynote speech at the opening of DIA China annual conference. She focused her remarks on her experiences at the agency over the last 6 years and highlighted the importance of globalization and regulatory science/innovation.
• Ms. Nancy Myers served as the key panelist for one of the two plenary sessions at the opening. The bilingual panel focused on actions being taken around the globe to improve the pharmaceutical R&D ecosystem and challenges that are being faced.
• Dr. Mac Lumpkin, Former Deputy Commissioner for International Affair at US FDA and now with Bill & Melinda Gates Foundation, provided his unique perspectives on building and having trust among the regulators at the other plenary session focusing on international collaboration;

FDAAA members also contribute significantly to the successful DIA meeting by chairing important sessions and participating as key speakers.

The following FDAAA members chaired four sessions at DIA:

• Dr. Chi-Wan Chen: Session chair for “Managing Post-Approval CMC Changes in China and the US (Part I and II)”
• Dr. Min Chen: Session chair for “Active Safety Surveillance”
• Mr. Shaoyu Chen: Session chair for “Generic Drug Forum (Part I)”
• Dr. Jinjie Hu: Session chair for “Drug-Diagnostic Co-Development and Regulatory Requirement and Challenges for Companion Diagnostic”

The following FDAAA members are the speakers and panelist of many topics:

• Dr. Andrew Chang: Speaker for “Managing Post-Approval CMC Changes for Biologics in a Global Market – Case Study)”
• Dr. Chi-Wan Chen: Speaker for “Managing Post-Approval CMC Changes for Chemical Drugs in a Global Market – Case Study”
• Dr. Min Chen: Speaker for “Overview of Recent US Postmarketing Requirements and Updates on Sentinel and DILIN (Drug-Induced Liver Injury Network)”
• Dr. Tao Du: Invited Panelist for Developing New Drugs from Traditional Chinese Medicine for Unmet Public Health Needs (Part II)
• Dr. David Lin: Speaker for “Overview of Regulations and Guidelines on Post-Approval CMC Changes for Chemical Drugs in the US”;
• Dr. Duu-Gong Wu: Speaker for “Overview of Regulations and Guidelines on Post-Approval CMC Changes for Biotechnological Products in the US”

Dr. Zili Li, FDAAA IN (left) and Mr. Yajun Zhao, CFDA (right), delivering the welcome speech at 7th DIA China Annual Conference in Shanghai China

Dr. Peggy Hamburg, Former Commissioner of US FDA, delivering the Keynote Speech at 7th DIA China Annual Conference in Shanghai China

Ms. Nancy Myers, Chair of FDAAA board of directors (right) with Dr. Steve Yang (left), Plenary Session Chair on Regulatory Science/Innovation at 7th DIA China Annual Conference

Dr. Mac Lumpkin (center), former deputy commissioner of US FDA, with Dr. Lin Su (right), Plenary Session Chair on International Collaboration, Mr. Xiangyu Wang (left) of CFDA, Dr. Yoshiaki Uyama of PMDA and Dr. Bernhard Schwartlander of WHO

Dr. Tao DU (2nd from left), FDAAA member with Dr. Yuming Chi (left), Tongren Tang Research Institute, Dr. Cheng Long (Center), Former Reviewer of CFDA, CAPT. Dennis Bashaw (2nd from the right) of US FDA and Dr. Jinhui Dou (right) of US FDA