SafetyObserver
@SafetyObserver
The leading #pharmacovigilance regulatory intelligence solution
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CIOMS has published the draft report of Working Group XII on Benefit-Risk Assessment... Our latest #Pharmacovigilance Regulatory Intelligence Report is out ! Read the Highlights and sign up for Free Alerts... bit.ly/3t4l5Pc
The ICH E6(R3) draft Guideline on GCP has entered the public consultation period... Our latest #Pharmacovigilance Regulatory Intelligence Report is out ! Read the Highlights and sign up for Free Alerts... bit.ly/3t4l5Pc
#Pharmacovigilance : What is the impact of the Reform of the EU Pharmaceutical Legislation ? Read our article and don't forget to sign up for these alerts on our website... safetyobserver.com/2023/05/04/eu-…
New MHRA GCP Inspections Metrics Report: 4 Critical Findings related to Pharmacovigilance... Our latest #Pharmacovigilance Regulatory Intelligence Report is out ! Read the Highlights and sign up for Free Alerts... bit.ly/3t4l5Pc
New Q&A Document on the Clinical Trials Information System (CTIS) and the EU Clinical Trials Regulation... Our latest #Pharmacovigilance Regulatory Intelligence Report is out ! Read the Highlights and sign up for Free Alerts... bit.ly/3t4l5Pc
New “quick guide for sponsors” to support compliance with the EU Clinical Trials Regulation... Our latest #Pharmacovigilance Regulatory Intelligence Report is out ! Read the Highlights and sign up for Free Alerts... bit.ly/3t4l5Pc
The US FDA has published the final guidance entitled “Format and Content of a REMS Document”... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for Free Alerts on our new website... bit.ly/3t4l5Pc
The Saudi FDA has published a revised version of its GVP Guideline, with some significant changes... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for Free Alerts on our new website... bit.ly/3t4l5Pc
ICH E19 Guideline on optimization of Safety Data Collection finalised and adopted by EMA for Europe... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for Free Alerts on our new website... bit.ly/3t4l5Pc
New FDA final guidance on RWD/RWE submissions... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for free alerts on our new website... bit.ly/3t4l5Pc
A new FDA draft guidance explains how generic sponsors will be able to submit electronic Safety Reports to FAERS. Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for free alerts on our new website... bit.ly/3t4l5Pc
PV DIGEST BY PUBHIVE - ARTICLE OF THE DAY: @ansm issues revised French GVPs - by @SafetyObserver bit.ly/3P5jGPO #ANSM #CRPV #pharmacovigilance #drugsafety #ADRs #RPV #QPPV #PSMF #caseprocessing #signalmanagement #signaldetection #pvdigest
safetyobserver.com
ANSM issues revised French GVPs - Safety Observer
The French Agency has published a new version of the local GVP Guideline and we are pleased to highlight the key changes.
The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies. Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for alerts on our new website... bit.ly/3t4l5Pc
News for the #Pharmacovigilance community in: 🗹 France (@LeemFrance) 🗹 Europe (@EFPIA) 🗹 and beyond (@The_RQA & @pvdigest1)
#Pharmacovigilance : @ansm issues revised French GVPs Read our article to find out about the main changes ! Don't forget to sign up for these alerts on our new website... bit.ly/3tnp9cA
#Pharmacovigilance : @ansm issues revised French GVPs Read our article to find out about the main changes ! Don't forget to sign up for these alerts on our new website... bit.ly/3tnp9cA
New Q&As published on the New EU Clinical Trials Regulation. Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for alerts on our new website... bit.ly/3t4l5Pc
The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports. Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for alerts on our new website... bit.ly/3t4l5Pc
Good #Pharmacovigilance Practices: New guideline published by the Drug Regulatory Authority in Pakistan...
Pharmacovigilance Inspections: Malaysian authorities issue guidance on voluntary GVP Inspections... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for alerts on our new website... bit.ly/3t4l5Pc
Pharmacovigilance Inspections: Malaysian authorities issue guidance on voluntary GVP Inspections... Check out our latest #Pharmacovigilance Regulatory Intelligence Report ! Read the Highlights and sign up for alerts on our new website... bit.ly/3t4l5Pc
EU adopts Standard for ePI for harmonised and up-to-date information on medicines... lnkd.in/d7d7ty9W
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