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FDA Experts to Speak at RAPS Horizons Conference
Date:3/19/2009

About Regulatory Issues in Telemedicine, Regenerative Medicine, More

ROCKVILLE, Md., March 19 /PRNewswire-USNewswire/ --Six expert representatives from the US Food and Drug Administration (FDA) will be among the speakers to address several hundred healthcare product regulatory professionals who will gather in San Francisco next month. The Regulatory Affairs Professionals Society (RAPS) will convene its 2009 RAPS Horizons Conference & Exhibition, 1-3 April at The Fairmont San Francisco. The RAPS Horizons conference draws experienced regulatory professionals from around the world to discuss healthcare regulations, regulatory strategy and the healthcare product business.

(Logo: http://www.newscom.com/cgi-bin/prnh/20070314/DCW091LOGO)

The regulatory professionals attending the RAPS Horizons Conference work with pharmaceuticals, medical devices, biotechnology and other related healthcare products. FDA speakers will address topics including advances in telemedicine, regenerative medicine using drug/device combination products, global health hazard analysis, medical devices for pediatric and humanitarian uses and cooperative efforts between FDA and Japanese regulators. Following is the schedule of FDA speakers. For the complete conference agenda, visit www.raps.org/horizons2009.

Wednesday, 1 April

  • Linda Ricci, biomedical engineer, Center for Devices and Radiological Health, FDA, Telemedicine: Getting Connected, 10:30 am-12:00 pm
  • Murray Malin, medical officer, Center for Devices and Radiological Health, FDA, Health Hazard Analysis in the Global Marketplace: Advice from the Experts, 1:30-3:00 pm
  • Erica Takai, PhD, scientific reviewer, Center for Devices and Radiological Health, FDA, Harmonization by Doing: Medical Device Development in Japan, 1:30-3:00 pm
  • Matthew Hillebrenner, chief, Circulatory Support and Prosthetics Branch, Center for Devices and Radiological Health, FDA, Regulatory Challenges for Pediatric/Humanitarian Use Devices, 3:30-5:00 pm

Thursday, 2 April

  • Kimberly Trautman, medical device quality expert, Center for Devices and Radiological Health, FDA, Avoid a Warning Letter: Practical Solutions for Compliance Around Supplier Quality Management, 10:30 am-12:00 pm
  • Steven Oh, microbiologist, Center for Biologics Evaluation and Research, FDA, Regulatory Approaches to Combination Products Involving Medical Devices and Tissues/Cells or Blood Products, 1:30-3:00 pm

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS.org


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SOURCE Regulatory Affairs Professionals Society (RAPS)
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