Module 1 – Regulatory and Quality Strategy


Monday 10th & Tuesday 11th July 2017


Module Schedule

Personalised Pre and Post Program Briefing with Dr Krystal Evans – at agreed times

Day 1 – Monday 10th July 2017 – can be attended by up to 3 representatives from your organisation

BioBriefing with Mary Beth Henderson – US Regulatory Landscape – Hills and Valleys at FDA

Time: Registration from 3:45pm for 4:00pm – 5:15pm session, followed by a networking
Where: Melbourne CBD

Day 2 – Tuesday 11th July 2017 to be attended by 1 representative from your organisation

Intensive Masterclass with Dr Mary Beth Henderson : US Market Access – Pathways for Clearance or Approval

This workshop will provide an overview of the steps and requirements necessary for US market access, 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. The workshop will provide the attendee with a background and overview of US quality, regulatory and clinical considerations for medical device development for the US market.

Time: Registration from 8:45am for 9:00am – 1:00pm session
Where: Melbourne CBD

Networking Lunch

Time: 1:00pm
Where: Melbourne CBD

1-on-1 Sessions with Dr Mary Beth Henderson

Time: 2:30pm – 6:00pm
Where: BioMelbourne Network, Milton House, Flinders Lane, Melbourne


There are 12 places available for each Module of this Program.  Priority will be given to organisations fitting the following criteria:

• Victorian based start-up or SME with less than 200 employees
• Existing validated prototype or market-ready medical technology product
• High potential for manufacture and export in next 12-24 months
• Demonstrated need for improved understanding of US market entry.

If you do not meet these criteria, you are still invited to complete an Expression Of Interest as there is an opportunity to detail your suitability for the Program.  Successful organisations will be contacted and invoiced for their selected module/s.

About Mary Beth Henderson: 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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