| Project Scope |
|---|
| Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3. |
Problem Statement
Problem Impact
Project Leads | Emails |
|---|---|
Christopher Smith, FDA | |
William Palo, AbbVie | |
Nicola Newton, PHUSE Project Assistant |
CURRENT STATUS Q1 2024 |
|---|
|
Objectives & Deliverables | Timelines |
|---|---|
TBC | Ongoing |
| Education Resources: |
|---|
| Education Page |
| Vision of Interactive Safety Reviews-Community Forum |
Safety Analytics Webinar Series 2023:
Date | Title | Speakers | Recording |
|---|---|---|---|
15 June | Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting | Greg Ball, ASAP Process Consulting, Jacqueline Corrigan-Curay, FDA, Barbara Hendrickson, University of Chicago & Brian Waterhouse, Merck | Recording |
| 13 July | Overall Safety Assessment – Standard Safety Tables and Figures | Jim Buchanan, Covilance), Mary Nilsson, Eli Lilly & Veronica Pei, FDA | Recording |
| 14 September | Greg Ball, ASAP Process Consulting, Mac Gordon, Johnson & Johnson), Peg Fletcher, MedAssessment & Scott Proestel, FDA | Recording | |
| 4 October | Jeremy Wildfire, Gilead, Steve Mallett, Veramed & Mat Soukup, FDA/CDER | Recording | |
| 16 November | Greg Ball, ASAP Process Consulting, Jacqueline Corrigan-Curay, FDA, Barbara Hendrickson, University of Chicago & Sheila Mahoney-Jewels, LifeSciHub | Recording |