Module 12 2019

Regulatory Authority Activities

• FAIR data ( F indable A ccessible I nteroperable R eusable) and Regulatory Health Authorities need structured standard data=CDISC • If legacy study start date should we be rethinking and programming as CDISC? Data ready to pool across Studies/Projects/TA’s • Ready for any Health Authority , including Pharmaceuticals and Medical Devices Agency (Japan) who only accept CDISC data from April 2020 • FDA can challenge why we are not able to provide CDISC packages when we propose to submit as legacy. Legacy filings incur many FDA questions post filing

The Organisation for Professionals in Regulatory Affairs

2019 Europe Interchange | Amsterdam, Netherlands | 6-10 May 2019

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