Agenda

The below agenda is an overview only and may be subject to change.

TimeSessionNotes
   Sunday, March 4th  
4.00 - 5.00pm Onsite registration opens  
5.00 - 7.00pm

Opening Session: Welcome Event & Working Group Overview

Sponsored by:

Plenary Session

7.30 - 9.00pm Workshop – Linked Data for Clinical Trials: An Interactive, Hands-on workshop Pre-registration required
   Monday, March 5th  
8.30 - 10.30am

Be an FDA Reviewer for the Day: Take an Interactive Journey through the JumpStart Process

Come join the FDA in a dynamic and interactive session where FDA staff will walk us through the reviewer process from data arriving to the FDA through the approval. Every attendee will have an opportunity to be a reviewer and make decisions along the way. This is a new and exciting session.

Plenary session

10.30 - 11.00am

Break & Networking
Sponsored by:

 
11.00 - 12.00pm Working Group Overview Session Working Group breakout sessions
12.00 - 1.00pm

Lunch & Networking
Sponsored by:

 
1.00 - 4.30pm Working Group Breakout Sessions Project Group breakout sessions
5.00 - 6.30pm

Poster Session

Sponsored by:

 
6.30 - 8.00pm Workshop – GitHub Environment: From Whitepaper Targets (TFL) to Shareable Scripts Pre-registration required
6.30 - 8.00pm Workshop – Maintaining the Clinical & Nonclinical Study Data Reviewer's Guides  Pre-registration required
   Tuesday, March 6th  
8.30 - 12.00pm Working Group Breakout Sessions Project Group breakout sessions
12.00 - 1.00pm

Lunch & Networking
Sponsored by:

 
1.00 - 2.00pm Working Group Wrap-Up Working Group breakout sessions
2.00 - 2.30pm Break & Networking
Sponsored By:

 
2.30 - 4.00pm

Vision and Collaboration: Integrating PhUSE, CDISC and Regulatory Stakeholders to ensure Public Health

Join CDISC, PhUSE and regulatory stakeholders in a dynamic and interactive session exploring what collaboration means and how we can optimise it for success. The session will initiate with a short overview from a CDISC, PhUSE and FDA panel presenting their view on future collaboration. Then the audience will be presented with a set of key questions they will discuss with individuals at their table with the goal of converging on a perspective they will share with everyone. The panel will then add their own perspective of the question and respond to the audience perspective. Bringing together many views on collaboration will strengthen our mission moving forward.

Plenary session
4.00 - 4.30pm Poster Awards & Closing Session Plenary session

 

 

 

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