APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Outcome statement
Outcome statement: Sydney meeting outcome statement
Outcome statement
Outcome statement: Singapore meeting outcome statement
Archive
GHTF Study Group 1 - Pre-market Evaluation documents
Archive
GHTF Study Group 2 - Post-market Surveillance/Vigilance documents
Archive
GHTF Study Group 5 - Clinical Safety/Performance documents
Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa, Closed 10 September 2019.
Consultation
IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa - Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Closed Wednesday, 31 May 2017.