Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

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TitleWorkshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Date03/05/2018 - 04/05/2018
LocationEuropean Medicines Agency, London, UK
SummaryThe European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017). Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper.

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Registration

  • Registration by invitation only.
  • Registration open until 31/03/2018.
  • Places limited.
  • Express interest to participate by writing to RP-stats-QA@ema.europa.eu

Related information

Statistical methodology for the comparative assessment of quality attributes in drug development