MTAA Members Only Event | UDI Implementations - Lessons Learnt with Robert Hankin, HIBCC

8:30am Wednesday, 18 September 2019
11:30am Wednesday, 18 September 2019
MedTech Workshop
Abbott Australia
299 Lane Cove Road
Macquarie Park, New South Wales 2113
Australia

***MEMBERS ONLY***

This member exclusive event is a unique opportunity for regulatory, operations and logistics professionals, as well as for other business and policy managers to hear directly from visiting expert Robert Hankin, President & CEO of Health Industry Business Communication Council (HIBCC) on UDI implementation challenges.

In the US, UDI has been a requirement since 2015 for certain high-risk medical devices. Its roll-out continues and will conclude for low-risk devices by 2020. Australia will implement a UDI system soon and it is imperative that medical device companies understand the implication for their business. Robert will cover technical aspects such as labelling requirements and uploading of data in the UDI database, and will discuss examples of lessons learnt. Also, he will focus on regulatory rules with examples and the issues to be aware of in both the US and Europe.

About the Presenter:

Robert A. Hankin, Ph.D. has served as President and CEO of the Health Industry Business Communications Council (HIBCC) since 1987.  In that capacity he has overseen the development of HIBCC from its’ early formation as a bar code labeling standards group to its’ current status as a provider of internationally-accredited healthcare supply chain product and customer identification standards.  HIBCC has been designated as a Unique Device Identifier (UDI) Issuing Agency for the US Food and Drug Administration (FDA) and the European Union (EU). 

Dr. Hankin earned his Ph.D. in Economics from Northeastern University in Boston, Massachusetts, USA, where he specialized in the healthcare sector.   Prior to being named HIBCC President, he held senior executive positions at the American Medical Association (AMA) and the American Dental Association (ADA), and served as a Managing Consultant  for a Cambridge, Massachusetts, USA - based research firm.    

The Details: 

Date:Wednesday, 18 September 2019
Time:08:15-08:30: Registration
 08:30-11:30: Workshop including morning tea
Venue:Abbott Australia
 299 Lane Cove Road
 Macquarie Park NSW 2113
Cost:MTAA Members Only: FREE

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Contact Information

Lorraine Hendry - Events & Program Manager