How Should We Collaborate to Realize the Value of RWE for IVD?
Date/Time: December 16, 2020 | 3:00 p.m.
Session Type: Scientific Session
Session Level: Intermediate
Session Overview:
This session brings together individuals from industry, regulatory agencies, laboratory, and a public/private partnerships to discuss the potential of real world evidence (RWE) for IVD regulatory purposes. These various perspectives are important to better enable the collaboration to realize the potential of RWE. There will be 3 speakers who will address the current gaps and practical opportunities to enable the use of RWE and real world data (RWD) followed by a panel discussion for questions.
Needs Assessment:
FDA has released guidance (2017) on the use of RWE for medical devices in regulatory decision making, stressing the need for relevant and quality RWD sources however it has yet to be determined how this data could be used for IVD regulatory purposes. Daily Laboratories captures a tremendous amount of unharnessed RWD data that could be better utilized. This session provides an overview of current challenges and opportunities to better collaborate across various stakeholders.
Intended Audience:
This session is intended for trainees, pathologists, laboratory directors, clinical chemists, medical technologists, regulators, data scientists, and information technologists.
Learning Objectives:
After this session, participants will be able to:
1) Identify the current opportunities for the use of RWD.
2) Describe current data sources and infrastructure to support use of RWD.
3) Outline the challenges of using RWD.
4) Identify potential ways laboratories can collaborate and support the use for RWD/RWE for regulatory purposes.
Expected Outcome:
After this session, participants will be able to:
1) Identify the current opportunities for the use of RWD.
2) Describe current data sources and infrastructure to support use of RWD.
3) Outline the challenges of using RWD.
4) Identify potential ways laboratories can collaborate and support the use for RWD/RWE for regulatory purposes.
Related Topics:
Data Analytics
Informatics
Speakers:
Sandra Siami, MPH, Medical Device Innovation Consortium
Current Opportunities and Challenges for the use of RWD
Riki Merrick, MPH, Association of Public Health Laboratories
The Challenge of Harmonization and Interoperability of Lab Data
Brian Jackson, MD, MS, University of Utah
Challenges in Communicating Manufacturers’ Method Specific Information within Lab Reports and Lab Data
Location:
Virtual
