Agenda

The conference will begin at 4pm on Sunday, June 9th and finish at 4pm Tuesday, June 11th.

Final detailed agenda


The agenda below is an overview, click above for the details agenda.

Time Session
   Sunday, June 9th
4.00–5.30 Onsite Registration
5.00–5.30

Introduction to the CSS for First-time Attendees

What makes the CSS special and how to get the most from the meeting

5.30

Welcome Refreshments

Sponsored by:

5.30–7.00

Opening Session: Welcome and Working Groups Overview

Join us on Sunday evening to hear from our Chair and for a new interactive session where there will be an opportunity to meet the Working Groups and Project Leads to discuss current and future initiatives

7.00–9.00

Workshops

Safety Analytics 

Let's Make a Knowledge Graph! - An Interactive, Hands-on Workshop

Educating for the Future: Community Engagement - Design Thinking Focus Group

   Monday, June 10th
8.30–10.30

CDER/CBER Perspectives in the Use of Study Data for Regulatory Reviews

Do you ever wonder what pharmacology/toxicology, clinical, or statistical reviewers are looking for during the regulatory review process at the FDA? Seven speakers from CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) present their perspectives in the use of study data and analytics for drug and biologics reviews. The topics of this presentation include (1) Technical Rejection Criteria (TRC) for study data; (2) the use of standardized SEND study data in nonclinical regulatory review in CDER; (3) the use of standardized study data and analytical tools for clinical safety evaluation in CDER; (4) study data traceability, transformation, mapping, consistency, and challenges for clinical reviews in CDER; and (5) study data considerations from a CBER perspective.

10.30–11.00

Break and Networking

Sponsored by:

11.00–12.00

Working Groups Breakouts

12.00–1.00

Lunch and Networking

Sponsored by:

1.00–5.00

Working Groups Breakouts

5.00–6.30

Poster Session

Sponsored by:    

6.30 - 8.30

Workshop

Machine Learning Programming

   Tuesday, June 11th
8.30–12.00

Working Groups Breakouts

12.00–1.00

Lunch and Networking
Sponsored by: 

1.00–2.00 Working Groups Wrap-Up
2.00–2.30

Break and Networking
Sponsored by:

2.30–4.00

Closing Session: What's Next? Defining the Next Opportunities for the CSS

An interactive collaboration session where we look at the impact of disruptive technologies and how PhUSE Working Groups and the CSS can continue to have an impact on product development and review processes, and continued community engagement.

Awards & Closing Remarks

 If you would like any more information, please click on the PhUSE CSS flyer below:

 

 

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