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Regulatory Affairs Professionals Society Medical Device Submission and Compliance Workshop to Feature FDA Regulators, Industry Experts


2/28/2013 11:24:00 AM

Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) will host a two-day workshop on medical device submissions and compliance that will bring together experts from industry and officials from the US Food and Drug Administration (FDA) to address how device makers can work more effectively with FDA and meet evolving regulatory expectations. The workshop, Medical Device Submission & Compliance Strategies for the US Market, will be held 7–8 March at the USP Meeting Center in Rockville, MD, USA.

Workshop speakers will include:

• Ashley Boam, MS, associate director, regulations and guidance, Office of Device Evaluation, Center for Devices and Radiological Health, FDA

• Ron Brown, recall branch chief, Division of Risk Management Operations, Office of Compliance, Center for Devices and Radiological Health, FDA

• Candice Burns, RAC, director, regulatory affairs, Boston Scientific Inc.

• Michael Chappell, senior advisor, Greenleaf Health LLC

• David Gartner, branch chief, Regulatory Policy and Systems Branch, Office of Compliance, Center for Devices and Radiological Health, FDA

• John “Girard” Griggs, MS, MS-RAS, RAC , interdisciplinary scientist, Office of Compliance, Center for Devices and Radiological Health, FDA

• Angela Krueger, regulatory advisor, product jurisdictional officer, Division of Cardiovascular Devices, Center for Devices and Radiological Health, FDA • Swaran Rajpal, consumer safety officer, Regulatory Systems and Policy Branch, Office of Compliance, Center for Devices and Radiological Health, FDA

• Eugene Reilly, program analyst, Office of Compliance, Center for Devices and Radiological Health, FDA

• Jeffrey Shapiro, JD, director, Hyman, Phelps & McNamara PC

• Marjorie Shulman, MBA, director, Premarket Notification 510(k) Program, Office of Device Evaluation, Center for Devices and Radiological Health, FDA

• Sharon Timberlake, MS, RAC, CCRA, vice president, regulatory affairs, Palomar Medical Technologies Inc.

Registration for this workshop is currently open. Interested members of the media should contact RAPS Senior Manager of Communications Zachary Brousseau at zbrousseau@raps.org or +1 301 770 2920, ext. 245.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org



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