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.