IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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EVVet3 Production - Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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