FDA International Regulators to Discuss Hurdles and Opportunities in Overseas Posts

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Country Directors of FDA Posts in China, India and Latin America to Examine International Efforts at DIA 2014 50th Annual Meeting

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FDA’s international mission to advance the safety of the global supply chain and drug development activities is spearheaded by its country directors.

The director for the Food and Drug Administration (FDA) in China, Christopher Hickey, will discuss FDA’s efforts to increase the number of inspectors in that nation and others as the global drug market continues to expand at a rapid pace. Hickey will speak during the session, “Challenges and Opportunities Facing FDA’s International Posts,” on June 18 at 1:30 p.m. at the DIA 2014 50th Annual Meeting, which will be held from June 15 to 19 at the San Diego Convention Center.

“FDA’s international mission to advance the safety of the global supply chain and drug development activities is spearheaded by its country directors. As this effort grows worldwide, the session will feature top regulators providing expert insight into the challenges they face,” said Barbara L. Kunz, DIA global chief executive.

In April, Hickey testified before the U.S.-China Economic and Security Review Commission on his work to ensure the safety and quality of medical products produced in China and imported to the U.S. To support these efforts, FDA aims to increase the number of U.S. staff posted in China from eight to 27 over the next few months—mirroring the significant increase in FDA’s inspection staff in India.

There are challenges to increasing FDA’s regulatory staff in 11 international locations, such as implementing quality manufacturing systems and inconsistencies in regulatory oversight among nations. Obtaining visa approvals for FDA staff also remains a hurdle: Last fall, Vice President Joe Biden met with Chinese authorities about resolving visa delays after many FDA staff applications were rejected.

Chaired by FDA’s assistant commissioner for international programs, Leslie Ball, the session on FDA’s international posts will feature Altaf Lal, director of FDA’s India Office, and Michael Rogers, director of FDA’s Latin America Office, along with Hickey.

ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in a neutral setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA, and regional offices covering North and South America (Horsham, Pa., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit http://www.diahome.org.

ABOUT DIA’s 2014 50th ANNUAL MEETING: Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development and life cycle management of medical products. The meeting aims to foster innovation that will lead to the development of safe and effective medical products and therapies for patients. For more information, visit http://www.diahome.org/dia2014.

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Tiffany Cohen
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