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Dr Sergio J Gadaleta Joins Editorial Advisory Board of Journal of Medical Device Regulation

London, 15 December 2005 -- Sergio J Gadaleta PhD, former FDA insider, current Director of Worldwide Regulatory Affairs at Ethicon Inc., a Johnson and Johnson Company and one of America's leading authorities on US and EU regulations for medical device and combination products, has been appointed to the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR). The announcement was made today by Victoria Clark, Editor of the quarterly publication, which reaches regulatory professionals in the US, Canada, the Middle East, Asia and Europe.

"Combination products are one of the areas that are of great interest to the readers of the JMDR, and Dr Gadaleta's unique experience as a scientific reviewer at FDA and his industrial regulatory experience is unparalleled", said Editor, Victoria Clark. "We are delighted to have him join the other respected professionals on our Editorial Advisory Board whose participation allows us to provide our readers with the latest information available on all facets of medical device regulation."

Dr Gadaleta holds the position of Director, Worldwide Regulatory Affairs at Ethicon Inc., a Johnson & Johnson Company. He is responsible for US and EU regulatory submissions for devices and combination products in the Ethicon portfolio and for the development of innovative global regulatory strategies and policies designed to achieve extraordinary business results. He was senior Scientific Reviewer at the Center for Devices and Radiological Health at the US Food and Drug Administration where he was responsible for reviewing 510(k), IDE, PMA, IND, and BLA submissions for products relating to the repair and reconstruction of hard and soft tissue. He achieved his PhD in Chemistry at Rutgers University, Newark, NJ and received the Charles K Sabat Distinguished Dissertation Award for Research in Biological Chemistry.

The other members of JMDR's Editorial Advisory Board are: Haroon Atchia, CEO and Technical Director of Quality First International Limited, London, UK; Jorge Garcia, Manager of the Medical Devices Laboratory Program at the TGA Laboratories in Australia; Rainer Hill, Deputy Director General of Germany's BVMed; Dr David Jefferys, Senior Regulatory Strategic Advisor at Eisai Europe Ltd in the UK; Ralph Jugo, Director of Regulatory Affairs at GMP Companies, Inc, Fort Lauderdale, USA; James Kuhn Jr, Director of QA/Regulatory Affairs at EP MedSystems Inc, West Berlin, USA; Paul Sim, Director of Regulatory Affairs & Quality Assurance Europe/Far East at Teleflex Medical, High Wycombe, UK; and Edward Wilson, Jr from Hogan & Hartson LLP, Washington DC.

On the Journal of Medical Device Regulation

The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents.

For more information

Please contact Marija Capek at Global Regulatory Press, phone number +49 (0) 621 16 623 26 or visit the Global Regulatory Press website at

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