The 21st Century Cures Act (Cures Act), signed into US law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. The law focuses on incorporating the perspectives of patients into the development of drugs, biological products, and devices in FDA’s decision-making process. Additionally, the Act seeks to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products.
The seminar will review the current impact of the Act for sponsors and FDA and the status of the programs that have been initiated as a result of the Act.
If you would like to participate in the full Going Global Module #3 – US – US Regulatory Environment: Finding your way through the FDA find out more and apply here
Date: Tuesday 21st August
Time: 3.45 pm registration, presentation & discussion 4.00 pm – 5.00 pm, followed by networking until 6.00 pm
Venue: Allens, Level 37, 101 Collins Street, Melbourne
BioMelbourne Network Members: $65
Non Members: $130
(Prices include GST.)
To check if your organisation is a member, click here
Note: Participants registered for the “Going Global” program will receive two registrations for this event
A full refund is given up to 7 days prior to the event
No refunds within 7 days of the event
Visiting US Expert:
Dr 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 30 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 from Northwestern University.
Going Global Program supported by:
This event is hosted by: