1. PhUSE European CSS Working Group
Non-Clinical Roadmap & Impacts on Implementation

2. 22nd June – Non-Clinical Breakouts
Topic
Speaker / Facilitator
Timings
Welcome
08:30 – 09:00
Breakout Session 1
Introduction & agencies perspectives on SEND
09:00 – 11:00
Breakout Session 2
Industry perspectives on SEND
11:30 – 12:30
Breakout Session 3
Looking Forward: future SEND evolution & use
13:30 – 14:30
Breakout Session 4
Identification of European hot topics & summation
15:00 – 16:00
Closing Remarks
16:30 – 17:00

3. Keywords from PhUSE EU CSS
Agencies perspectives on SEND
Excellent contributions from FDA and PMDA
Interest from EU
Industry perspectives on SEND
Implementation of different SEND solutions across CROs and pharma
Challenges with SEND implementation

4. Keywords from PhUSE EU CSS
Looking Forward: future SEND evolution & use
Leveraging SEND for data mining and visualization
NextGets project in EU
Novartis use-case
The CDISC SEND team pipeline
Identification of European hot topics & summation
Discussion on existing PhUSE projects

5. KNOWLEDGE-SHARING