Regulatory and Reimbursement Panelists

  • Rosina Robinson, RN, M.Ed., RAC, Principal Consultant, Regulatory Services

    Rosina has over thirty years of experience in regulatory affairs and healthcare delivery. She has authored numerous successful FDA and Health Canada for products representing a variety of medical specialties, with particular expertise in the regulation of cardiovascular, minimally invasive and general surgical devices. She guides clients through all types of premarket regulatory and clinical trial activities, and is especially skilled at facilitating face-to-face communications between clients and the appropriate FDA center, including CDRH and CBER. She has published numerous articles related to regulatory affairs and FDA regulation of medical devices. Rosina is a member of the Regulatory Affairs Professionals Society, and the Association of Operating Room Nurses. She is a registered nurse, holds a M.Ed. from Bridgewater State College, and is Regulatory Affairs Certified. Rosina also served as an adjunct professor in the Northeastern University Master of Science in Regulatory Affairs program, from 2003 to 2007.


    Corinne Lebourgeois, Managing Director, MedC. Partners

    Graduate in Sciences (B.Sc.) and Business (MBA), Corinne Lebourgeois started her career in 1989 as Product specialist with W.L.GORE & Associates where she managed the non cardiovascular surgical product line and developed the aesthetic surgery market. Corinne joined ETHICON, a Johnson & Johnson division, in 1992 as Senior R&D Manager in charge of the product development department. Her main responsibilities included product evaluation from concept screening to clinical trials management. She worked in different therapeutic fields such as orthopaedics, cardiac surgery, open and endoscopic general surgery and successfully CE marked new products.
    In 1995 she also acted as Lead Marketing Manager for Ethicon meshes business in Europe and supervised MITEK product marketing activity in France. In 1997 Corinne was directly involved in the creation of GYNECARE, the new Women’s Health division of J&J, sole responsible of the Marketing. She built Gynecare uro-gyneco market in France from scratch, managing operational and strategic marketing that led to multimillion euros successes. She also initiated the Direct To Patient communication strategy in order to educate patients with “taboo conditions” such as incontinence and menorrhagia. Corinne moved to the US in 2000 where she worked as an independent Marketing Consultant for start up companies (Acueity Inc, Contura, Navion Inc) and Non Profit (Asthma Care Center) and corporations (Gynecare, Clinical Device Group, Dey Inc) where she developed European market entry strategies successfully. In 2002, she also graduated in “E Business and Technology” from UC Berkeley where she studied the new economy with an emphasis in “e Marketing” and “Crafting for e Business Models” and where she was introduced to the venture capital community. Back in Europe in 2003, Corinne set up her consultancy business in Switzerland where she continues to support SMEs and start-ups in their marketing and business development activities.
    In 2005, Corinne found MC Medical Consultant Partners Sarl in Aubonne and partnered with Marie José Plique to further develop her consulting activities. Nowadays, they work under the MedC.PartnersTM brand name.


    Richard Naples, SVP, Corporate Regulatory Affairs and Compliance, BD

    Richard Naples is the Senior Vice President of Corporate Regulatory Affairs and Compliance for BD (Becton, Dickinson and Company), Franklin Lakes, NJ, a world leading medical technology and diagnostics company. He has worldwide responsibilities for BD’s premarket regulatory submissions and postmarket compliance systems, reimbursement, and public policy. 

Mr. Naples has over 30 years in the diagnostics industry, including experience in laboratory management, as an FDA scientific reviewer, and as a senior corporate regulatory leader for large diagnostics manufacturers. He is currently the co-chair of the AdvaMed Diagnostics Task Force. He has led/participated in numerous industry-wide efforts to ensure regulatory policies that foster timely patient access to safe and effective medical devices.

    Mr. Naples has a Bachelor of Science degree in Medical Technology from Youngstown State University in Ohio. Prior to joining BD, he held positions at St. Elizabeth Hospital Medical Center, Southwest Florida Regional Blood Bank, FDA Center for Biologics, Evaluation and Research (CBER), and Roche Diagnostics.

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  • Conference Info:

     

    Date: June 26-27, 2013
    Location: The Metropolitan Club, New York City


    Audience: Institutional investors, high net worth individual investors, family offices, business development executives throughout the US and Europe building and financing high growth medical technology, health care and life science companies.

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