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November 2022

Safety Observer 194

ICH E19 Guideline on optimization of Safety Data Collection finalised and subsequently adopted by EMA for Europe.

Released 08-Nov-2022
Pages 36
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Report 194 — Highlights

ICH E19 Guideline

ICH has announced that the ICH E19 Guideline on optimization of Safety Data Collection has now been finalised and the EMA subsequently adopted the guideline for Europe.

Safety Reporting in the UK

Further to the introduction of the combined review process, the British HRA has updated its Safety Reporting guidance for Clinical Trials conducted in the UK.

New FDA Draft Guidance

The FDA has published a new draft guidance to address the processing of Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.

PVA Toolbox

TransCelerate has published new material resulting from its Pharmacovigilance Agreements Optimization (PVAO) Initiative.

PV Inspections

Several authorities have published information related to Pharmacovigilance Inspections. This includes a new Risk Assessment Survey that companies should submit to the Australian TGA.

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