Change at the FDA: How the current regulatory environment impacts device development-Lisa Olson, MBA-03/08/2016 - 6:00pm

Event Information
Event Topic: 
Change at the FDA: How the current regulatory environment impacts device development
Event Date: 
03/08/2016 - 6:00pm
Event Location: 
Wilson Sonsini Goodrich & Rosati- 650 Page Mill Road, Palo Alto, CA
Speaker Information
Event Speaker: 
Lisa Olson, MBA
Event Speaker Title: 
President
Event Speaker Company: 
RCRI, Inc.
Event Speaker Bio: 

Lisa Olson has over 20 years of experience in the medical device and biologics industries providing contract research services to start-up through Fortune 100 companies. She has extensive technical experience in pre-clinical research, including in vitro and in vitro biocompatibility, genotoxicology and toxicology models.
Lisa’s work now centers primarily on strategic leadership for a regulatory consulting and clinical research organization that helps medical device manufacturers bring products to market. Lisa received a B.S. degree in microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas. She has co-authored numerous ISO Biocompatibility Standards, served as a co-chair of the AAMI/ISO Technical Advisory Group on Cytotoxicity, and sat on working groups related to materials safety for the Association for the Advancement of Medical Instrumentation (AAMI) and the American Society for Testing and Materials (ASTM).

Event Details
Cost: 
$6 - Students/In-transition - Members only
$11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members
$25 - Walk-ins
Event Details: 

In response to public and legislative pressure over the past several years, the FDA has been actively working to evolve to meet expectations for safer devices while supporting device innovation. To make the change, the FDA is starting by examining its very foundations, evaluating how it operates, developing quality systems, and working to effectively manage talent. Further, the agency is continually evaluating how it regulates medical products. While all signs point to a more progressive and effective organization, the constant change leads to a lack of transparency that can mean getting clearances and approvals difficult to get.

This session will focus on FDA strategic priorities, what changes are pending and what these events mean to device manufacturers.