Event Information

Cooley LLP and Deloitte Getting the CE Mark in Europe: Paths to Progress, Boston, MA

COOLEY
500 Boylston Street
Boston, Massachusetts
02/14/2013
7:45 AM - 11:00 AM

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Cooley LLP and Deloitte Europe of Rotterdam, Netherlands, are pleased to invite you for the following event.

Europe, the Old World that formed the roots for the greater Boston Area, can provide new horizons for US medical device companies. Pursuing a CE Mark in Europe to register and launch your new product offers interesting and immediate advantages:

  • Faster market approval processes (2-3x faster compared to the lengthy and expensive U.S. FDA pathway);
  • Earlier market access and sales;
  • Accelerated development time, resulting in faster market access, and longer patent horizon;
  • Generation of clinical data to bolster the FDA approval process and enhance the prospects for US FDA approval;
  • Entry to a growing market of 503 million inhabitants with access to, and need for, promising technologies in healthcare; and
  • Possibilities for additional funding and grants, resource support, and infrastructure for penetration of the European market.

Launching in Europe can be a faster pathway to early market access into a significant healthcare market and provides a compelling opportunity from a financial perspective.

During the seminar, experts from Deloitte together with Cooley partner, John Hession, and industry professionals will take you step-by-step through the process of getting into Europe. They will speak on best practices, potential pitfalls and first-hand experiences with regard to CE registration, market access, regulatory pathways, reimbursement, supply chain and the accompanying tax and legal structures.

Come hear our experts discuss the opportunities, challenges, considerations and strategic planning you should consider if you are contemplating launching medical products and drugs in Europe.

EXPERTS

Ömer Saka, MD Msc, is director with Deloitte where he leads the market access and HEOR Group. He is a qualified medical doctor, obtained his MSc from London School of Economics on health economics and policy. He is an expert on market access and pricing strategy, health technology assessment, cost effectiveness/budget impact assessment, evidence synthesis, outcomes research and clinical data studies. Omer has provided market access strategy advice to a number of large and middle sized industry firms in Europe/US (including GSK, J&J Pharma and Medical devices business, Bayer, BMS, Pfizer, St Jude Medicals, UCB). 

Jasper Evers, Msc, is a director with Deloitte where he co-leads the Dutch life sciences industry practice and is lead of the LifeTrack initiative. Jasper Evers has twelve years of experience in the area of international tax structuring at Andersen / Deloitte of which he spent the last six years in the life sciences sector. In his life sciences industry role Jasper serves venture capital firms, start-ups, academia as well as multinationals such as: J & J, Abbott, Actavis, Cardinal Health, Profibrix and others. 

Susan A. Posner, is a Vice President with Health Advances where she co-leads the Medtech Practice Group, and she has worked on over 150 project engagements, with a wide variety of clients ranging from small start-ups to some of the largest public companies in the industry. Susan's work with these companies has helped to optimize the value of products and technologies through extensive market evaluations, due diligence of M&A opportunities, and the development of strategies for sales and marketing efforts. She has extensive experience in the device sector, including minimally invasive and interventional products, in addition to combination products and clinical areas focusing on women's health, anesthesiology and pain management. Susan has published articles in a number of industry journals including a recent Medtech Insight article focusing on the value proposition for medtech products and is currently a director on the MassMEDIC board.

MODERATOR

This discussion will be moderated by Cooley Partner John Hession.


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