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Program Location
Crowne Plaza Hotel
4290 El Camino Real
Palo Alto, CA 94306
Supporting Organizations
Media Partners
Registration & Fees
MDMA Member: $295
BayBio, BIOCOM and CHI Members: $395
Non Member: $495
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Premarket Approval (PMA) and 510(k) Premarket Notification Seminar
MEDICAL DEVICE MANUFACTURERS ASSOCIATION (MDMA)
March 18, 2010
Palo Alto, CA
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Newly confirmed speaker
Heather Rosecrans, Director of 510(k) Staff, Office of Device Evaluation, Center for Devices and Radiological Health
Heather S. Rosecrans is the Director of the Premarket Notification (510(k)) Staff, Program Operations Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration. Ms. Rosecrans is responsible for administrating the 510(k), classification, reclassification, 513(g), and class II petitions for exemption programs for CDRH. Ms. Rosecrans began her career in 1977 at the Bureau of Drugs’ National Center for Antibiotic Analysis. In 1978 she joined the relatively new Bureau of Medical Devices as a Scientific Reviewer in the Division of Clinical Laboratory Devices. From 1980 to 1987 she served as a Consumer Safety Officer for the Premarket Approval (PMA) Staff. Ms. Rosecrans joined the 510(k) Staff in 1987 and became the Director of the 510(k) Staff in 1993. Ms. Rosecrans received a bachelor’s degree in biology from Pfeiffer College.
Attendees will learn the regulations governing 510(k) and PMA premarket submissions from leading FDA attorneys, industry representatives, and FDA officials. This seminar is designed to help companies
- Understand the requirements of submissions
- Provide practical advice on how to prepare them
- Help manage and maximize communications with FDA
- Avoid fraud and abuse in clinical trials
- Understand compliance issues
The program will provide valuable insight from a variety of perspectives and give companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.
Speakers Include:
Nicole L. Wolanski, Director, PMA Program, Office of Device Evaluation, Center for Devices and Radiological Health *invited
Heather Rosecrans, Director of 510(k) Staff, Office of Device Evaluation, Center for Devices and Radiological Health *invited
Mark Gordon, Vice President, Global Regulatory Advocacy and Policy, Boston Scientific Corporation
Mark Leahey, President & CEO, MDMA
John Manthei, Partner, Latham & Watkins LLP
Phil Phillips, President and CEO, Phillips Consulting Group
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Who Should Attend? Regulatory Affairs, Clinical Affairs, Quality Assurance
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