Irish Medical Device Association Conference 2012

With 20 years experience in the medical device industry, he has overseen the successful launch of eight electronic medical device products in the past fourteen years.

Bill Doherty is Managing Director of Cook Ireland Ltd and Executive Vice President of Cook Group Europe with responsibility for Cook’s EMEA business.

A lawyer by training, Jacqueline Minor began her career in the European Institutions at the Court of Justice in 1984. In the Commission, she spent 16 years in the Directorate-General for the Internal Market, heading, successively, the units responsible for the regulated professions.

In 2009, Ann O’Connor was appointed as Director of Human Products Authorisation and Registration with the Irish Medicines Board (IMB) with responsibility for pre-market activities relating to medicinal products and medical devices.

Tanja joined Eucomed in September 2008 and heads Eucomed’s Public Affairs team. She has more than 10 years experience in public and governmental affairs in Brussels, working at and with the EU institutions and trade association bodies.

Currently he is Head of Regulatory and Clinical Affairs at BSI Healthcare. He acts as vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical evaluation Task Force (CIE), and Medical Device Expert Group (MDEG).

Marjorie Shulman has been with the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration since 1984. She is currently Acting Director, Premarket Notification (510(k)) Program in the Office of Device Evaluation (ODE).

Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 180 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations.

Recent trends in US regulation and implications for industry (an industry perspective)

Dominik Reterski is Senior Director Regulatory Affairs EMEA at Covidien. He also acts as the Chairman of Eucomed RAC Emerging Markets and Mecomed RAC.

Ruby currently works with Cook Medical's China Branch as Head of Regulatory Affairs. She is a member of the China national standard committee TC 194 & TC106 sub-branch and involved in multiple national standards drafting. She also joined SFDA CMDE program as key enterprise representative.

Gaurav Verma is Head of Regulatory Affairs for Boston Scientific India Hub with over 12 years of experience in Pharmaceutical Quality Assurance and Regulatory Affairs.

Nessa Childers is an Irish Labour Party politician and Member of the European Parliament (MEP) for the Ireland East constituency.