Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019
On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.
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Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs
On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.
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EMA SME Office Newsletter – Issue 49
On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).
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Explanatory Note to GVP Module VII
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR).
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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 14 May 2020 the FDA updated the guidance for Industry, Investigators, and Institutional Review Boards.
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