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: 
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
$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.

Payment Options Dec 12th Evening Event

Attention B2DG members: You must login to your account first to see the members' early-bird admission rate.
If you are not a B2DG member or if you had missed the early-bird deadline, the registration fee is $20. Please follow these instructions to register.

We use PAYPAL to process your online payment. Print and bring a copy of your online receipt with you. If space permits, walk-ins are welcomed; please be prepared to pay $25 at the door (cash or check). There is no refund, exchange, or transfer. Thank you for your cooperation.
To register now, please select your meal preference from the pull-down menu below and enter the attendee's information. Then click on the "Pay Now" button to reach the PayPal payment page. Each attendee must be registered separately.
Make sure you enter the attendee's meal choice, name, and email address.

Meal Choice
Name of Attendee
Email Address