14 May 2008
10:30am –12:00 pm ET
Program Description: This Webcast focuses on the changes to the EU Medical Devices Directive and the Food and Drug Administration Amendments Act of 2007 and their implications for regulatory professionals. Speakers begin with an overview of the most important recent developments regarding these laws. They then discuss the consequences of these developments for medical device and pharmaceutical companies producing borderline products, providing practical advice on how to deal with resulting issues and reduce compliance risk.
Learning Objectives: Upon the Webcast’s conclusion, participants should be able to:
- Summarize the recent developments regarding changes to the EU Medical Devices Directive and the Food and Drug Administration Amendments Act of 2007
- Identify resulting legal and compliance risks
- Apply the new rules to deal with those risks
Audience: Regulatory professionals, in-house counsel, sales and marketing professionals and anyone else within the organization who should be able to identify legal and compliance risks relating to the FDA Amendments Act of 2007 and the EU medical device rules.
Professional Levels: I, II, III
Speaker:
Cost: RAPS Members: $325 USD; Nonmembers: $400 USD
Cost is per site—unlimited participants!
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What is a Webcast? A webcast is a live, interactive event—very much like a private talk-radio program, with the added feature of viewing visuals on the web. To listen to the audio portion of the seminar, you need only a touch-tone telephone (a speaker phone is required if more than one person per site will listen). To access the Internet portion of the seminar, you need a separate Internet connection with a current version of Internet Explorer or Netscape, in addition to the telephone line.
Cancellation and Refund Policy: Written cancellations received by 12:00 pm EST on Tuesday, 13 May 2008 will be refunded the registration fee minus a $100 administrative fee. Refunds will not be granted for failure to attend, changes to the agenda or speakers or for sites that do not meet the minimum system requirements needed to attend a RAPS Webcast. Cancellations must be received in writing via email at raps@raps.org or via fax. RAPS DOES NOT ACCEPT PHONE CANCELLATIONS.
Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.
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Speaker Bios
Laurie Clark is a partner in King & Spalding's Washington, DC office. Her practice focuses primarily on the Food and Drug Administration's (FDA) regulation of medical devices. She specializes in premarket submissions, including 510(k) premarket notifications, investigational device exemption (IDE) applications, pre-IDE submissions, premarket approval (PMA) applications, amendments and supplements, reclassification petitions, de novo review submissions, device designation requests for combination products, and requests for humanitarian use designation. In addition, Clarke has extensive experience counseling medical device manufacturers and tissue processors regarding compliance with FDA laws and regulations, including labeling requirements, medicine, dental, ophthalmic, otolaryngology, infection control and general hospital devices. She represents clients ranging from small startup companies to multinational corporations on a broad spectrum of medical device issues. Clarke has been practicing FDA law for 17 years. She received her JD from Stanford University, MPP from Harvard University and BA cum laude from Smith College.
Erik Vollebregt is of counsel in the Amsterdam office of Greenberg Traurig. His practice focuses on technology, healthcare and life sciences. He has broad experience in both litigation and transactional work in these areas, as well as in the application of antitrust law to medical technology and pharmaceutical products. Vollebregt’s experience includes advising medical devices companies about regulation of borderline products, parallel imports, regulatory issues relating to clinical investigations, labeling requirements for medical devices in multiple jurisdictions, advising medical device companies about business compliance and conducting business compliance audits, advice and litigation about regulatory issues relating to CE marking, advice about misleading and comparative advertising for medical devices. He has experience with a wide range of medical devices and therapies, among others orthopedic surgery, cardiovascular, wound care, tissue engineering, in vitro diagnostics, diabetes care and blood pressure meters.
RAPS Contact
John P. McKenzie
Senior Program Manager, Education
jmckenzie@raps.org