Safety Analytics – Project Volunteer Board

Interested in joining one of the Safety Analytics Working Group Projects? The projects below welcome new volunteers.

Project Scope:

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.

Regular Project Meeting Day/Time:

• Leads to confirm

Key Skills:

• Medical background for Stage 2

• MDs who are experts in DILI assessment

Project Scope:

• Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3.

• This is an ongoing project that will deliver multiple outputs per year:

• Webinars (3-4 per year)

• Continued enhancements to the safety library (link)

Regular Project Meeting Day/Time:

• Bi-Weekly: Wednesday 15:00-16:00 GMT

Key Skills:

• Gather ideas for project deliverables

• Help coordinate and facilitate webinars

• Develop and maintain content for safety library

• Engage personal and professional networks to publicise project deliverables