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Michael Gropp

Former Medical Technology International Regulatory Policy Executive

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After 3-1/2 years of direct patient care experience, Michael Gropp joined the Medical Devices and Diagnostics Division (MDD) of Eli Lilly and Company in 1980. He held various engineering, regulatory affairs, quality assurance, and compliance positions.

From 1989 to 1995, Mr. Gropp was Director, Regulatory Affairs, MDD Europe, based in London and Brussels. In 1994, when Guidant Corporation was formed in a spin-off from Lilly, Mr. Gropp joined Guidant and was promoted to Vice President, Quality Assurance, Regulatory Affairs, and Clinical Research for Devices for Vascular Intervention. Mr. Gropp then served as Guidant’s Chief Compliance Officer from 1996 until 2000, when he took the position of Vice President, Global Regulatory and Public Policy, based in Brussels. As a result of a merger, Mr. Gropp held the same position with Abbott Vascular from April to November 2006.

Mr. Gropp was Vice President, Global Regulatory Strategy with Medtronic, Minneapolis, USA, from November 2006 until retiring from corporate life in May 2013.

Mr. Gropp was a special representative for international affairs and policy to the Board of Directors of the Advanced Medical Technology Association (AdvaMed)(Washington, D.C.) and Chair of the Eucomed (Brussels) International Affairs Task Force. He was a member of the Global Harmonization Task Force (GHTF) Steering Committee from its inception in 2000 until GHTF was disbanded in 2012. He was an active contributor to the Asia Harmonization Working Party from its founding in 1994, continues to serve as an AHWP adviser, and was a frequent trainer in regional conferences. Mr. Gropp has led efforts to include medical device regulatory harmonisation in the Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum and was a member of the advisory board to the APEC Harmonization Center in Seoul. He has served as a member of the Scientific Advisory Group to the World Health Organization’s International Clinical Trials Registry Platform project.

On behalf of Eucomed, Mr. Gropp was Co-Chair of the Global Medical Technology Alliance (GMTA), a group of national medical technology associations focused on international policy advocacy.

In October 2010, Mr. Gropp received the Regulatory Affairs Professionals Society (RAPS) Richard E. Greco Award in recognition of his work to help harmonize global medical device regulations and advocate for regulatory professional development. From June 2011 he has chaired the RAPS Global Advisory Council looking to recommend ways in which RAPS can help develop professional regulatory capacity, especially in less developed economies. Since 2014, he has served as RAPS faculty and coordinator for the National University of Singapore (NUS) – RAPS graduate certificate course in international medical device regulatory affairs.

Mr. Gropp has given lectures for the Stanford University Global Biodesign course, was named to the Advisory Board of the newly-formed Centre of Regulatory Excellence (CoRE) at Duke-NUS Graduate Medical School, Singapore, and most recently, was named as a temporary advisor to the World Health Organization working group on development of a model regulatory framework for medical devices. He also serves as a temporary advisor on good regulatory practices.


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