Top Drug and Device Regulatory Leaders Join George Washington University’s Advisory Board for Its Regulatory Affairs Program

Article ID: 611191

Released: 4-Dec-2013 5:00 PM EST

Source Newsroom: George Washington University

Newswise — WASHINGTON — Global leaders have joined GW’s Regulatory Affairs Advisory Board. Dr. Daniela Drago, Program Director Regulatory Affairs, stated: “We’re delighted to have a group of accomplished professionals with diverse backgrounds. They will provide key contributions to our strategic direction. Their input and expertise will excel our program, create networks and enable us to keep our finger on the pulse of the industry”.

GW School of Medicine and Health Sciences has recently established a regulatory affairs program. It offers two degrees in regulatory affairs: a Master of Science in Health Sciences (MSHS), and a Graduate Certificate. One of the main goals is to prepare graduates to meet the challenges of dealing with FDA regulated products. The program is dedicated to preparing and fostering the next generation of international regulatory leaders. In line with a commitment to continuous improvement, the program formed a permanent advisory board. The board will provide a perspective from different facets of the drug and device industries, and create networks for students and graduates. Insights from the board’ members will ensure that the curriculum incorporates skills that meet today’s business needs.

Members of the advisory board include:

Aomesh Bhatt, Regulatory and Medical Affairs Director, Reckitt Benckiser Group

Marlene Bobka, Senior Vice PresidentFOI Services, Inc.

Joe Bocchino, Senior Associate Dean for Health Sciences, Associate Professor The George Washington University

Paul C. Brooks, Senior Vice President, Healthcare SolutionsBSI Group

Chris Cain, Vice President, Clinical OperationsZOLL Medical Corporation

David E. Chadwick, Director, Regulatory Affairs, Regulatory ScienceCook, Inc.

Tricia DeSantis, Vice President, Global Regulatory AffairsJohnson & Johnson Consumer Companies

Daniela Drago, Director Clinical & Translational Research and Regulatory Affairs, Assistant Professor The George Washington University

Surendra Gokhale, Head, Clinical Trials Regulatory Management Group, Global Drug Regulatory AffairsF. Hoffmann-LaRoche Ltd.

Scott Huie, Vice President, Corporate and Product ComplianceValeritas, Inc.

Tara Kambeitz, Global Marketing ManagerUL LLC, Health Sciences Division

Kazen Kazempour, President and CEOAmarex Clinical Research

Elizabeth Mathew, Regulatory Affairs LeaderGE Healthcare Services

Susan Rolih, Executive Vice President, Regulatory and Quality SystemsMeridian Bioscience Corporation

Nancy Singer, FounderCompliance Alliance, LLC

John C. VillforthFormer Director of FDA's Center for Devices & Radiological Health (Retired)

Michael Viscido, Corporate Director, Quality Systems and ServicesIkaria, Inc.

For more information about the Regulatory Affairs program at GW, visit: the GW School of Medicine and Health Sciences:Founded in 1825, the GW School of Medicine and Health Sciences (SMHS) was the first medical school in the nation’s capital and is the 11th oldest in the country. Working together in our nation’s capital, with integrity and resolve, the GW SMHS is committed to improving the health and well-being of our local, national and global communities.


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