RAPS Philadelphia Chapter event: FDA Regulation of Medical Software: Past, Present and Future

When:  Mar 24, 2011 from 18:00 to 21:00 (ET)

Join your regulatory colleagues from across the Greater Philadelphia area for an evening of networking and an expert presentation entitled, “FDA Regulation of Medical Software: Past, Present and Future.” This meeting is sponsored by the RAPS Philadelphia Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. A dinner buffet will be available for all meeting registrants and participants may claim two RAC recertification points.

This event will focus on the US Food and Drug Administration’s (FDA) regulation of medical software, from software integrated into medical devices to electronic health records and more. In this quickly evolving area, FDA has recently stated that it intends to increase the scope of regulation. This presentation seeks to provide an understanding of the current status of regulation and possible areas for change in the future.

Topics to be covered include:

  • A brief overview of the evolution of FDA's regulation of medical software
  • A discussion of what the agency regulates today
  • Possible directions for future regulation
Date/Time:

Thursday, 24 March 2011

6:00 pm pm - Registration Opens
6:00–7:00 pm - Registration Check-in, Networking and Dinner
7:00–8:30 pm - Speaker Presentation
8:30–9:00 pm - Question and Answer Period
Location:

Days Hotel (formerly the West Chester Inn and Conference Center)
943 South High Street
West Chester, PA 19382

Directions can be found online, or by calling +1 610 692 1900
Registration:

RAPS members: $55.00     Nonmembers: $70.00
» Register Today
Speaker:

Yarmela Pavlovic, attorney at law, Hogan Lovells US LLP
Yarmela Pavlovic is an Associate with the law firm of Hogan Lovells US LLP, focusing primarily on the US Food and Drug Administration’s (FDA) regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. Pavlovic has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs, and PMAs), as well as providing advice on a variety of other device-related regulatory issues. She also works frequently with regulated industry, including medical software manufacturers, to assess the classification of and regulatory requirements applicable to individual products. Previously, Pavlovic defended medical device manufacturers and pharmaceutical companies in relation to product liability litigation. She holds a law degree from the University of Michigan.
Local Contact:

Ed Narke, RAPS Philadelphia Chapter Co-Chair, +1 610 329 1219
Lori Burns, RAC, RAPS Philadelphia Chapter Co-Chair, +1 484 713 2186
RAPS Contact: Wesley Carr, +1 301 770 2920
More information

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