7/28/21 Steering Committee Meeting
This month we had a productive steering committee meeting with 26+ participants.
The topics and all resources and content, along with a video recording of the meeting, are provided below.
We look forward to hearing from you .
Please find the slides from the meeting here.
Watch the recording of the meeting above.
0:00-3:30 Intro + Opening remarks
3:31-5:08 What does PIcc look like, practically?
5:09-6:05 Ethics
6:06-12:04 Truthing & Validation updates
12:05-13:02 Trainees update
13:04-13:51 Intro to new member from Pharma, Abigail
13:52-15:35 Multiplex Immunohistochemistry/Immunofluorescence Technique: The Potential and Promise for Clinical Application
15:36-17:35 MDIC surrogate sample framework
17:36-27:15 Privacy Project Project
27:16-34:40 VALID ACT of 2021
34:41-37:31 EMA regulatory science 2025
37:32-39:53 Advisory from U.S. Surgeon General
39:54-58:05 Standards Project update from Kingsley
58:06-59:06 Talk proposal
59:08-end Regulatory Education for Industry (REdI)
Meeting Summary
Ethics Workgroup/Subpage:
Link here
Workgroup Updates:
Truthing & Validation (link)
Trainees
Next speaker event will feature Siba el Hussein (details will be posted on Trainees page)
Multiplex Immunohistochemistry/Immunofluorescence Technique: The Potential and Promise for Clinical Application
Tissue Multiplex Analyte Detection in Anatomic Pathology – Pathways to Clinical Implementation (Wharton et al., 2021) (link)
MDIC surrogate sample framework
Privacy Pilot Project (P3)
Solicit and combine the relevant documents
Will schedule a meeting - meeting info to be posted here
Several recent (regulatory) developments
21st Century Cures Act
•https://www.hhs.gov/hipaa/index.html
•HHS Privacy Program
•State-level changes
•GDPR vs. HIPAA
VALID Act of 2021
Click on the slide to download the bill.
EMA Regulatory Science 2025
Affects 25 nations and 450 million people
Fundamental changes
Overview document link here
Click here to download the presentation by Kingsley Ebare.