PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
Why AI Governance Is Becoming a Differentiator in PV Careers
FDA’s 2026 Good AI Practice principles emphasize context of use, multidisciplinary expertise, data governance, lifecycle management, and clear essential...
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Why EMA’s MSSG Matters When Shortages Become Safety Issues
EMA says the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) was established under Regulation 2022/123 and is responsible for...
CTIS Sponsor Training in June 2026 Signals the Growing Importance of Trial-System Skills
EMA has scheduled a CTIS sponsor end-user training programme for 8–11 June 2026. The event listing places the training firmly within the live operational...
MHRA Strengthens Warnings for Gabapentinoids, Benzodiazepines and Z-Drugs
MHRA has reviewed how risk information is communicated for gabapentinoids, benzodiazepines, and z-drugs and concluded that warnings on these medicines need to...
What the FDA’s New AEMS Signal Page Means for Pharmacovigilance Teams
The FDA’s new Adverse Event Monitoring System (AEMS) includes a page dedicated to new safety information or potential signals of serious risks identified...
MHRA Announces Bayer Recall Over Impurity Above Acceptable Limit
MHRA has published a Class 3 Medicines Recall for Bayer Plc, various products, EL(26)A/12. The agency said Bayer is recalling all stock of the listed products...
MHRA Warns Patients About Fake Mounjaro KwikPen 15mg Pens
The UK’s Medicines and Healthcare products Regulatory Agency has warned that some patients may have been dispensed fake Mounjaro (tirzepatide) KwikPen 15mg...
EMA PRAC Warns About Aseptic Meningitis Risk with Ixchiq Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of a safety signal involving aseptic meningitis with Ixchiq, the live...
FDA Recommends Earlier MRI Monitoring for Patients Taking Leqembi
The U.S. Food and Drug Administration has said it is recommending an additional, earlier MRI for patients with Alzheimer’s disease taking Leqembi (lecanemab)....