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

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

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

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

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