10th July – BioBriefing – US Regulatory Landscape: Hills and Valleys at FDA

Monday 10th July – 4:00 pm – 6:00 pm

Dr Mary Beth Henderson is the Senior Principal Advisor in Regulatory Affairs and Quality Systems at US based RCRI® (Regulatory & Clinical Research Institute, Inc.).

Dr Henderson will be in Melbourne for the Export Ready for North America Program and will provide an overview of recent FDA updates, shifts, and additions to the medical device regulatory landscape at this BioBriefing.

Areas to be discussed include: when software becomes a medical device, regulatory expectations around digital health devices and cyber security; and the impact of recent guidance in developing regulatory strategies for medical devices.

Date: Monday 10th July 2017
Time: Registration from 3:45pm for 4:00pm – 5:15pm session, followed by a networking
Where: Melbourne CBD


Please do not book tickets for this event if your organisation has registered for or intends to apply for the Export Ready for North America Program.

BioMelbourne Network Members: $65
(Price includes GST)

Bookings are open to BioMelbourne Network Members only at this stage – here

To check if your organisation is a member, click here

Mary Beth Henderson, Ph.D., MBA

Vice President of Regulatory Affairs and Quality Systems and Senior Principal Advisor, RCRI (US)

Mary has worked for over 26 years in medical device and biotechnology industries. She brings experience in strategic regulatory, quality, R&D, and business development roles to her project work. As a Senior Principal Advisor for RCRI, Mary has worked with clients to develop domestic and international regulatory strategies, draft submissions, and negotiate their approval by FDA and/or other regulatory agencies.

Leveraging her years of R&D and product development experience, Mary often works with product development teams or early-stage companies during initial phases of product design to provide regulatory support and guidance. Her chemistry and biotechnology expertise help to efficiently support projects involving combination products or medical devices incorporating biological materials. Mary has an MBA from the University of Massachusetts and a PhD in Chemistry.


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