Materiovigilance in EU
01 Jan 2019
"Vigilance" means close monitoring. Materiovigilance means close monitoring of any undesirable occurrence resulting from a medical device by means of ...
Safety data exchange agreements
27 Oct 2018
The current outlook in the pharma world is to jointly develop and market medicinal products. Different companies take responsibility for bringing the ...
Pharmacovigilance Indicators
14 Oct 2018
The prime objective of the pharmacovigilance indicators is to measure the existence and performance of major pharmacovigilance activities. They provid...
Pharmacovigilance: Compassionate Use Program in Europe
31 Aug 2018
The compassionate use programs (CUP) according to the European Regulation (EC) No 726/2004 art 83 lay down Community procedures for the authorization ...
Nutravigilance
07 Aug 2018
Nutraceutics_ These days, due to a busy and stressful lifestyle, people have erratic dietary habits and are more prone to diseases. A balanced diet ...
Importance of literature screening
08 Jul 2018
Screening literature is not only a mandatory requirement for marketing authorisation holders (MAH) but it is also the major and important source of in...
Pharmaceutical Industry opt - outsourcing of pharmacovigilan...
03 Jun 2018
Pharmaceutical industry is growing exponentially due to the development of innovative therapies and newer indications along with advancements in drug ...
Medical Dictionary for Regulatory Activities (MedDRA)
05 May 2018
Medical Dictionary for Regulatory Activities (MedDRA) MedDRA is a standard medical terminology used to facilitate sharing of regulatory information. M...
Risk Management System
04 Apr 2018
Pharmacovigilance, in simple terms, can be defined as the processes and science of monitoring the safety of medicines and taking steps to reduce the a...
Data Migration Approach for Handling Legacy Safety Data -Pha...
06 Mar 2018
Pharmaceutical industry, in today's world, is expanding with an immense business potential; with a steady growth in developed markets but rapidly grow...
Steady-State Bioequivalence Study (EMA) Full Replicate 2-Per...
02 Feb 2018
In line with the guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) effective from ...
Signal Detection Methodology @ Lambda
02 Feb 2018
Introduction: Following its inception in 2009, Pharmacovigilance at Lambda has grown organically and signal management activities are conducted by Lam...
