The MSBA's Food Drug & Device Law Section Presents
Call Me Maybe: Recent Challenges in FDA Communications
Focusing primarily on the medical device arena, this lunchtime seminar draws on recent real-life situations to provide lessons in optimizing communications with FDA, whether the topic is getting a device into clinical trials, into the market, or into the US. Get advice on ways you can optimize your FDA communications for more successful interactions while reviewing highlights of the new FDA Safety and Innovation Act and the proposed Unique Device Identification regulation.
Amy Fowler, RAC, J.D. , Principal Advisor, Regulatory Affairs, Regulatory & Clinical Research Institute, Inc.
Amy Fowler began her regulatory affairs career in 1992 at 3M, handling a wide variety of medical device regulatory challenges, including 510(k)s, global submissions, MDRs, labeling reviews, establishment registrations and device listings. She led a division transition to compliance with the European Union Medical Device Directive; has acted as management representative for a medical device quality system, managing FDA and Notified Body inspections; and assumed a pharmaceutical regulatory role in support of both the CMC and clinical aspects of New Drug Applications, Investigational New Drug Applications, and Drug Master Files. She obtained approval of a pediatric indication for a drug/device combination product encompassing a complex delivery system. In addition to her depth of medical device regulatory experience, Amy has experience in Financial Disclosure regulation, the Prescription Drug Marketing Act, advertising and promotion and face-to-face meetings with FDA on submissions. Amy has a Bachelor of Science degree in Chemistry from the University of Minnesota and has held her RAC(US) since 1995. She has a Juris Doctor degree from Hamline University School of Law. Amy’s education and experience bring a wealth of knowledge and understanding to both medical device and pharma health care businesses.
1 hour of Standard CLE credit applied for.
The event code is 172203.
Lunch will be provided.
Date: Wednesday, October 24, 2012
Time: Noon to 1:30 p.m.
Lunch will begin at Noon, followed by the CLE program from 12:15 p.m. - 1:15 p.m.
Location: MSBA Offices,
600 Nicollet Mall #380,
Minneapolis, MN 55402
Food Drug & Device Law Section Members: $15.00
Join the Food Drug & Device Law Section and attend this meeting for FREE (You must be a current MSBA member but not a FDD Section member. Pay the 12-month section dues and your section membership will expire on June 30, 2013.): $28.00
MSBA Member But Not A Food Drug & Device Law Section Member: $20.00
Non-MSBA Members: $25.00
Law Students: Free
Teleconferencing is available. Teleconferencing instructions will be sent by e-mail on Tuesday, October 23. Registrations must be received no later than October 19 in order to receive the instructions.
Refunds will be processed for cancellation requests received in writing on or before noon on the registration deadline. Requests should be directed to the event contact person listed at the bottom of this notice. Cancellation requests received after this time are not eligible for refunds. You may send a colleague in your place if you are unable to join us and the registration deadline has passed.