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.
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.
The FDA has published a new draft guidance to address the processing of Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.
TransCelerate has published new material resulting from its Pharmacovigilance Agreements Optimization (PVAO) Initiative.
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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