Enlightening RBM Process Innovation - The PPH plus Newsletter
In its latest Newsletter, PPH plus informs about the boosted cooperation between Europe (EC and EMA) and the US (FDA) concerning inspection data sharing. The new confidentiality commitment signed in August 2017 enables the US regulator to share non-public and commercially confidential information relating to medicine inspections with EU regulators.
Additionally, the periodical refers to the recent EMA’s reflection paper on the pharmaceutical development of medicines for use in the older population (public consultation from 1 August 2017 to 31 January 2018).
The bulletin alludes to the recently published peer-reviewed summary of the PUEKS project (Applied Clinical Trials online, 22 August 2017), which provides guidance on how to streamline and enhance risk-based quality management in clinical trials.
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