Sponsored Webcast: Prepare for EU & Other Global Regulators: UDI Data Management

When:  Nov 13, 2019 from 1:00 PM to 2:00 PM (ET)


Medical devices and in vitro diagnostic medical devices started with UDI regulatory requirements in the US. Looking to 2020 and beyond, regional channels around the globe are emerging with specific requirements for UDI. Starting with EU EUDAMED, how will your organization respond to meet UDI data management around the globe?

This discussion will review current regional unique device identification initiatives, timelines, and expected future challenges in implementing UDI, concentrating on EUDAMED. Our featured speakers will discuss best practices in planning and preparations for electronic data submissions, registration scenarios and unique regional differences that have become publicly known.


Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

 

Learning Objectives:

Upon conclusion of the program, you will have explored the following topics:

• The known requirements of emerging regulatory channels and commercial UDI adopters

• Best practices in planning for electronic data submissions for UDI

• The differences and similarities of FDA UDI and EU UDI, touching on device registration scenarios

 

Who Should Attend:

• Unique Device Identification Team Members

• Global Strategy Business Managers

• Regulatory Affairs/Operation Leaders

• Product Managers and Business Analysts

• Manufacturing, Operations, and Supply Chain Leaders

• Quality Leaders

• Medical Device IT Support


Speakers:

Gary Saner, sr. manager, information solutions life sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. With an understating of regulations, business requirements and systems, Saner has helped shape and implement solutions at Reed Tech for data management, validation and processing of drug labeling and medical device unique device identification content. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

John Lorenc, sr. manager, regulatory solutions life sciences, Reed Tech

John Lorenc specializes in operational and technical management processes related to regulatory data electronic submission initiatives and requirements for both the medical device and pharmaceutical industry. He has advanced experience with FDA Structured Product Labeling (SPL), specifically with respect to electronic drug product labeling and listing requirements. Lorenc is a Certified SCRUM Product Owner and a member of the Advisory Board of the Medical Devices Group.


Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.