Safety Observer 190
The ANSM has published a revised version of the French Good Pharmacovigilance Practices.
Report 190 — Highlights
EU CTR: New Q&As
New guidance has been published in relation to the New EU Clinical Trials Regulation (EU CTR). The Q&A Document on the EU CTR has been revised and new Q&As published for Complex Clinical Trials and on the interface with the Regulation on in vitro diagnostic medical devices.
ANSM: French GVPs
The French Agency has published a revised version of the French Good Pharmacovigilance Practices (GVPs), which comes in replacement of the version issued in February 2018.
South Africa: New PV guidance
The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Systems”, which covers the requirements for the QPPV and PSMF, amongst others.
FDA: Medical Gases
The FDA has published a proposed rule that covers the postmarketing safety reporting requirements for certain medical gases.
Artificial Intelligence & PV
CIOMS has started a new Working Group XIV to cover Artificial Intelligence in Pharmacovigilance. The May issue of the “Drug Safety” journal also includes a series of articles on Artificial Intelligence and Machine Learning.
