BEIJING, CHINA—JUNE 7, 2012— DIA, the premier organization dedicated to knowledge exchange that fosters innovation to raise the level of health and well-being worldwide hosted a special invitation-only vaccine workshop and roundtable held during the 4th Annual China Meeting: Collaboration and Innovation in China from May 20-23 at the Shanghai International Convention Center, Shanghai, China.
DIA organized a workshop and roundtable in conjunction with the Bill and Melinda Gates Foundation. The half-day vaccine workshop included a series of presentations and a half-day closed-door roundtable discussion where the World Health Organization (WHO), China State Food and Drug Administration (SFDA), and manufacturers identified best practices for ensuring WHO prequalification as well as training and information to ensure compliance with international requirements.
“A recent assessment by WHO shows that SFDA is complying with international standards for vaccine regulation,” says Paul Pomerantz, DIA Worldwide Executive Director. “The approval and implementation of the revised WHO requirements for prequalification creates a need to provide technical support for members of the SFDA in China.”
China is a leading producer of vaccines at affordable pricing, hence a great opportunity for China to serve as the conduit to vaccine supply for developing countries. It is crucial that the SFDA representatives have the most pertinent information on the WHO requirements to ensure successful manufacturing of vaccines.
“This workshop helped to bridge the gap between what is currently being done and what needs to be completed to ensure WHO prequalification. As part of an effort to raise global immunization rates to 90%, it is imperative that the SFDA and the manufacturing sites have the same understanding of the requirements needed to meet WHO prequalification, to ensure product approval,” says John J. Hu, PhD, DIA Program Chairperson, Vice President and General Manager, United States Pharmacopeia-China.
The 4th China Annual Meeting featured an SFDA Center for Drug Evaluation (CDE) town hall meeting where participants were provided with an opportunity to ask questions of senior SFDA leaders, two new API regulatory workshops, and a session facilitated by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. www.diahome.org