Pharmacovigilance trainings: You love it or hate it, but can not ignore it Yes, you read it right! You love it or hate it but can not ignore it. If someone says WHY? The reason is quite clear and simple..it is regulatory requirement👮Need to understand further refer my previous blog "Pharmacovigilance...
Showing posts with label PV. Show all posts
Showing posts with label PV. Show all posts
May 7, 2022
Sep 2, 2020
Marketing Authorization Holders (MAH) should know these 10 things from BREXIT- MHRA Guidance on Pharmacovigilance Procedures
Drug Safety Guru
Brexit, MHRA, Pharmacovigilance, PV, Submission
MHRA has published
updated guidance on pharmacovigilance procedures on 01 September 2020 and new
rules will be effective from January 2021 (post-Brexit transition period comes
to an end this year).
1.
General Approach to the operation of pharmacovigilance
This document
outlines the submission...
Dec 16, 2018
Pharmacovigilance Abbreviations / Acronyms
Drug Safety Guru
Abbreviations, Acronyms, Drug Safety, Pharmacovigilance, PV
Term
Description
ADCO
Addendum to Clinical Overview
ADRs
Adverse Drug Reactions
AE
Adverse Event
AERS
Adverse
Event Reporting System
ANDA
Abbreviated
New Drug Application
ATC
Anatomical
Therapeutic Chemical (in Anatomical
Therapeutic
Chemical
...