23 January 2017

In November 2016, the Board approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors, and product quality issues.

Please now find on the Multidisciplinary page the Concept Paper on the extension of the remit for the M1 PtC WG.