New FDA Liaison Opens Up

June 1, 2009

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2009, Volume 0, Issue 0

Hear from the first FDA liaison in the Office of International Programs.

New FDA Liaison Opens Up

As part of the U.S.-EU Transatlantic Administrative Simplification Plan, FDA and EMEA will both send one staff member to each other's agency headquarters to serve a two-year term as liaison in the Office of International Programs. FDA has selected 20-year agency veteran Janice Soreth, MD, whose experience includes serving as CDER's director of the division of Anti-Infectives and Ophthalmology as well as working in CBER and the Office of Combination Products/Office of the Commissioner.

Janice M. Soreth

Applied Clinical Trials spoke with Dr. Soreth about her upcoming move to London and how she feels about her new position as Deputy Director (Medical Products) Europe, Office of International Programs, U.S. FDA.

Q: What influenced you to apply for this position?

A: The opportunity to serve abroad, to advance the mission of FDA through global health diplomacy touched a deep chord within me. My first job after residency was overseas, far from Washington, in the setting of an emerging island nation. It was an eye-opener in many respects, especially regarding availability of health care and medical products beyond the borders of the United States.

Q: Why is this exchange important?

A: Part of FDA's statutory mission is to work with foreign regulatory authorities to harmonize regulatory requirements and try to reduce regulatory burdens, so establishing these liaison positions fits right in with that mandate. Beyond that, it's a common sense thing to do. Medical product development is interconnected globally like never before, so the United States will get a lot out of close collaboration with EMEA, using a risk-based, life-cycle approach for medical products.

Q: How would you describe the impact this exchange will have on the U.S. and EU agencies?

A: We have very cordial ties now, but there are limits to what you can do with phone calls and visits. I think that embedding an official in each other's agency will have a very positive effect on our cooperation, on understanding the way each partner thinks.

Q: How will all your experience at FDA help you serve?

A: I wouldn't feel comfortable taking this assignment if I had not had the opportunity to serve in a range of jobs in the agency, starting as a primary reviewer, as well as experience living abroad. I'm grateful that the FDA has taken my professional development seriously and has given me the chance to, among other things, go through the Leadership Development Program. And I can't say enough about the mentoring I've received over the years, especially that of Drs. Mac Lumpkin and Janet Woodcock.

Q: What do you hope to accomplish?

A: I'm proud of the way we work as an agency team...of how seriously the FDA takes its mission of safeguarding the U.S. public; and from the outset, I want to communicate our positiveness and professionalism. And in an age of global health concerns, I think it's more urgent than ever to build close relationships with our international partners.

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