Data Sharing and Data Privacy - what every statistician needs to know
Data sharing, data transparency and data privacy are areas that continue to evolve. For example, EMA Policy 70 is now effective with proactive publication of submitted clinical overviews and study reports. It is becoming more common for clinical trial data to be used to support scientific questions beyond the objectives of the original study.
The intent of this webinar is to provide an outline to pharmaceutical statisticians of key issues and concepts everyone dealing with and sharing patient level data should be aware of.
Presentation #1 Sharing clinical trial data externally – key data privacy concepts every statistician should know (Janice Branson and Nicola Orlandi (Novartis)) Click here to view the slides
Presentation #2 Data Sources to help inform drug development – what you give is also what you get (Sally Hollis (Phastar) and Rebecca Sudlow (Roche)) Click here to view the slides
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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