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Competence, Training and Conduct Requirements for Regulatory Reviewers, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Friday, 14 October 2016.

Marketing Review Report Work Instruction, Good Regulatory Review Practices, Coordinator Ken Cavanaugh, Closes 8 July 2022

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.

Proposed update to document on Post-Market Clinical Follow-Up Studies, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu, Closed 11 December 2020.

Proposed update to Clinical Evaluation documents, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu - Center for Medical Device Evaluation (CMDE), Closed Wednesday, 5 June 2019.

IMDRF Terminologies for Categorized Adverse Event Reporting: terms, terminology and codes, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa - Pharmaceuticals and Medical Devices Agency (PMDA), Closed Friday, 2 December 2016.

IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Closed Friday, 12 October 2018.

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.

Considerations for the Selection of IMDRF Adverse Event Terminology