Regulatory Roadshow: Regulation and Reimbursement to enter the US Market



Adam Steadman, VP of Clinical Development, Syneos Health US, will present on Regulatory & Reimbursement Pathways for Successful Entry into the US Market. The event is kindly supported by Syneos Health and The Australian Research Council Training Centre for Medical Implant Technologies (ARC CMIT), University of Melbourne.


During this session we will discuss the medical device evidential requirements of both regulators and payers in the world’s single most important healthcare market. Discussion will include the regulatory pathways that are available to medical device manufacturers, and how reimbursement is impacted by the regulatory pathway. We will provide case studies of companies that got it wrong, resulting in market access delays and greater development costs, and some that nailed it first time around!


While discussing the US, we will also round out some considerations that should be made when considering bringing new products to market in Europe, and how your US strategy should be fully integrated with your CE marking strategy – no longer does it make sense to plan these separately.


This event is recommended for clinicians, students, start-ups and emerging companies, medical device companies and the broader life sciences sector.


Biography:

Adam Steadman has more than 14 years' experience in a clinical research organization (CRO) in a number of financial, operational and business development roles. These roles include CFO of a cardiovascular focused CRO, and General Manager of a cardiovascular core laboratory. Adam has extensive knowledge of the Medical Device & Diagnostics clinical trial arena in the US, Europe and Asia Pacific and is an operational expert in Ambulatory Blood Pressure Monitoring. As VP of Clinical Development, he is now responsible for the global operations of the Medical Device & Diagnostics Business Unit. Adam has been instrumental in the development of the SyneosOne service offering in medical device - which combines both clinical and commercial services to provide a unique end to end delivery from first in human through full global commercialisation.


Event details


Date:

Wednesday 25 March 2020

Time:

11:30am - 11:45am Registration 11:45am - 12:45pm Seminar 12:45pm - 1:30pm Networking lunch


Venue:

University of Melbourne University House at The Woodward Level 10, Melbourne Law School 185 Pelham St, Carlton 3053


Cost:

AusBiotech Members: Free Clinicians: Free

Students and researchers: Free

Non-member Attendees: $75


Registration:

https://www.ausbiotech.org/events/event/regulatory-roadshow-regulation-and-reimbursement-to-enter-the-us


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