Periodic Safety Update Reports (PSURs):-A. PSURs submitted after exit daya. MHRA will continue to accept EU version of PSURsb. MHRA specific request for information needs to be included in specific annexurec. MHRA has developed its own submission requirements and develop a list of...
Sep 30, 2019
Sep 22, 2019
Service Level Agreement (SLA) in Pharmacovigilance perspective
Drug Safety Guru
Drug Safety, Pharmacovigilance, Service Level Agreements, SLA
Service Level
Agreement (SLA) is generally mutual commitment between service provider and a client. In pharmacovigilance
industry, pharmacovigilance
service provider and pharmaceutical company (client) come together in agreement
for various PV activities. This could be single PV activity or End...
Sep 14, 2019
Article 31 -EMA to review ranitidine medicines following detection of NDMA
Drug Safety Guru
Article-31, EMA, NDMA, Ranitidine
Under Article 31 of Directive 2001/80/EC, the review of
ranitidine containing medicines was initiated at the request to the European
Commission. This review will be carried out by the Committee for Medicinal
Products for Human Use (CHMP). The CHMP opinion will then be forwarded...
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
...
Dec 4, 2018
Privacy Policy
Drug Safety Guru
Privacy Policy
Effective date: December 04, 2018
DRUG SAFETY & PHARMACOVIGILANCE (PV) ("us", "we", or "our") operates the https://pvbasics.blogspot.com blog (hereinafter referred to as the "Service"). This page informs you of our policies regarding the collection, use, and disclosure of personal...
Disclaimer
Drug Safety Guru
Disclaimer
This is a
personal blog. The information contained in this blog is for general
information purpose only.
All views
express on this site are my own and do not represent the opinions of any entity
whatsoever with which I have been, am now or will be affiliated. I am not responsible for any errors...