Activities

FDAAA International Network Conducts GxP Training at DIA China, Shanghai

At the 6th Annual Drug Information Association (DIA) China conference held May 11-14, 2014 in Shanghai, the FDAAA International Network (FDAAAIN) sponsored and ran three important regulatory science training sessions related to GxP:

  1. Pre-conference Workshop: Principles for Successful GxP Inspections - A Hands-On Interactive Approach based on FDA, WHO, and Industry Experiences;
  2. How GxP Impacts the Medical Product Review and approval Decisions (Part 1 and Part 2), and
  3. Regulatory Perspectives on Drug-Device Combination Products in the US and China. FDAAA members were active in speaking and sponsoring sessions beyond these as well. Travel and per diem were paid for by the FDAAA member employers.

The all day Pre-conference Workshop was led by Florence Houn MD MPH (FDAAAIN Co-chair and VP, Celgene US) and Zili LI MD MPH (FDAAAIN Co-chair and Deputy Country Director for China R&D, Bill & Melinda Gates Foundation), and focused on the principles for Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance and Risk Management Practices (PV and RM).

The speakers and topics were:

  • Gang WANG, PhD (Assistant Country Director, US FDA China Office): GMP
  • Mark J. Goldberger MD MPH FIDSA (FDAAA and Vice President, AbbVie): GCP
  • Dylan (Dalin) YAO MD PhD (FDAAA, SVP and CSO, Joinn Laboratories, Inc.): GLP
  • Bruce Close (Director, Celgene): PV and RM
  • Chi-wan CHEN PhD (FDAAAIN Planning Group, Ex. Director Pfizer), Duu-Gong WU PhD (FDAAA, Senior Consultant, Pharmaceutical Product Development), David Lin PhD (FDAAA, Senior Consultant, Biologics Consulting Group), and Gang WANG PhD: GMP Exercises
  • Jim (Xiaoxiong) WEI MD, PhD (FDAAA, Medical Director, MedPace): GCP Exercises
  • Bruce Close and Florence Houn MD MPH: PV and RM Exercises
  • Shaoyu CHEN (FDAAA, Partner and Managing Director, Covington & Burling): Discussion Facilitator

Preconference GxP Workshop: Dr. Gang WANG (podium) with Bruce Close (left).

The half-day session on How GxP Impacts the Medical Product Review and Approval Decisions (Part 1 and Part 2) was led by Florence Houn and FENG Yi (Former CFDA/CDE associate center director and Senior Advisor, Covington & Burling). Speakers and their topics were:

  • Mark J. Goldberger MD MPH: The Medical Reviewer's Perspective
  • Chi-wan CHEN PhD: Assuring Product Quality for New Drug Approvals: CMC Review and Pre-Approval Inspections
  • YANG Zhimin, MD (CFDA/Center for Drug Evaluation, Director of Office of Clinical Review I): CFDA: Current and Future Directions
  • Dylan (Dalin) YAO MD PhD: How GLP Impacts the Medical Product Review and Approval
  • Gang WANG PhD: Biologics GMP Inspection - FDA's Perspective
  • HSU Lih-jiuan, MD (Taiwan FDA/Center for Drug Evaluation, Senior Executive Officer): TFDA Current and Future Directions

How GxP Impacts the Medical Product Review and Approval Decisions (Part 1 and Part 2): From Left to Right: Dylan (Dalin) YAO, HSU Lih-jiuan, Florence Houn, Mark J. Goldberger, YANG Zhimin, FENG Yi, and Gang WANG. Missing: Chi-wan CHEN

Finally, the FDAAA International Network (FDAAAIN) sponsored and ran an important CMC-GMP session on Regulatory Perspectives on Drug-Device Combination Products in the US and China. The session was led by Chi-wan CHEN (FDAAA International Network Planning Group, Executive Director Pfizer). Speakers and topics were:

  • Duu-Gong WU PhD (FDAAA, Senior Consultant, Pharmaceutical Product Development), David Lin PhD (FDAAA, Senior Consultant, Biologics Consulting Group): Drug-Device Combination Products in US
  • Jiaxin TIAN (CFDA, Center for Medical Device Evaluation, Senior Reviewer): Overview of Current Regulations and Guidelines for Drug-Containing Devices in China