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IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B

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Consultation documents

N43-PD1 for Annex B IMDRF Terminology for Categorized AER with Annex B description rev
AE WG (PD1 Annex B)/N43R1 – Annex B
Reference Mapping document

Please use the comments template to provide comments on the Proposed Document and email comments to imdrf-aewg-chair [at] pmda.go.jp.

Comments - PD1 Annex B N43 - IMDRF Terminologies for Categorized AER terms, terminology and codes - March 2017