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Going Global: Module #3 – US – US Regulatory Environment: Finding your way through the FDA

August 21, 2018 @ 3:45 pm - August 24, 2018 @ 3:00 pm AEST

Mary Beth HendersonFor the third module in the Going Global program, we welcome visiting international expert Dr Mary Beth Henderson, Vice President of Regulatory Affairs and Quality Systems and Senior Principal Advisor, RCRI from the 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.

Module components

This module has three components:

  1. BioBriefing: 21st Century Cures Act – US Regulatory Impact (Tues 21st August)
  2. Workshop: Pathways to the US Market: Demystifying FDA (Wed 22nd August)
  3. Advisory session (Thu 23rd or Fri 24th August – individual timeslots to be advised)


BioBriefing: 21st Century Cures Act – US Regulatory Impact
Tuesday 21st August – Registration at 3.45pm, presentation & discussion 4.00pm – 5:00pm, followed by networking until 6.00pm
Venue: Allens, Level 37, 101 Collins Street, Melbourne

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 are unable to participate in the full module, you can register for the module BioBriefing.

Workshop:  Pathways to the US Market: De-mystifying FDA
Wednesday 22nd August – 8.45am – 5.00pm
Venue: East Tower Suite, Level 35, Sofitel on Collins, 25 Collins Street

The workshop will aim to provide attendees with an understanding of the nuances of the FDA clearance/approval processes.  An overview of the steps and requirements necessary for US market access will be provided, including a discussion of when R&D should shift to design control, importance of risk files in developing a medical device, approaches to US regulatory strategies, pathways to market, key FDA guidance documents to consider, and when clinical evidence will be needed to support a submission.

Although the focus will be on the medical device pathways, biologics, drugs, and combination product pathways will also be discussed.  Finally, a discussion of how to leverage information across worldwide geographies will be presented.

The workshop will provide the attendee with a background and overview of US quality, regulatory and clinical considerations for medical product development for the US market.

A 30-minute advisory session with Mary Beth
Meetings will be held on Thursday 23rd and Friday 24th August – We will contact you to arrange a suitable time for your 30-minute meeting.  You are not required outside of this time on these 2 days.
Venue: BioMelbourne Network, 25 Flinders Lane, Melbourne


Registration for each module includes:

  • Two attendees at the module BioBriefing
  • A full-day intensive workshop for one company representative
  • A 30-minute advisory session with the module leader (up to four representatives from your organisation can attend)
  • An invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets. These will run in September and November 2018.

The fee is $550 (incl. GST) for your first Going Global module, then $440 (incl. GST) for any subsequent module(s).


August 21, 2018 @ 3:45 pm
August 24, 2018 @ 3:00 pm
Event Category:


BioMelbourne Network
+61 3 9667 8181


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