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EMA finalises pharmacovigilance guidance

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-...

EMA consults on risk-based auditing of pharmacovigilance systems, communicating safety info

The European Medicines Agency is seeking feedback on two draft modules to be included in its good pharmacovigilance practice guideline (GVP). The latest modules pertain to pharmacovigilance audits an...

News and press releases: Two modules of guideline on good pharmacovigilance practices released for public consultation

The European Medicines Agency has released two further modules of the guideline on good pharmacovigilance practices (GVP) for public consultation.

News and press releases: European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices

The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today.

News and press releases: Two further modules on good pharmacovigilance practices released for public consultation

The European Medicines Agency has released two further modules of the guideline on good pharmacovigilance practices (GVP) for public consultation until 21 September 2012.

Training for New Pharmacovigilance Framework

Published date:  06/06/2012 Summary:  Training for New Pharmacovigilance Framework...

EUCARF Seminar: Pharmacovigilance

The EUCARF Seminar "Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety" from 6th to 7th June 2013 in Freiburg provides the basis of the...

Updated sports concussion guideline: Athletes with suspected concussion should be removed from play

With more than one million athletes now experiencing a concussion each year in the United States, the American Academy of Neurology (AAN) has released an evidence-based guideline for evaluating and ma...

Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug-drug interactions: a PharmacoVigilance study in France.

OBJECTIVE: Our aim was to characterize Adverse Drug Reactions (ADRs) related to drug-drug interactions (DDIs) related to involvement of cytochrome P450 (CYP450) isoenzymes in a pharmacovigilance datab...

Pharmacovigilance teaching in UK undergraduate pharmacy programmes.

PURPOSE: Pharmacists in the UK are able to report spontaneous adverse drug reactions (ADRs) to the Medicines and Healthcare Products Regulatory Authority. The level of reporting by UK pharmacists rema...

The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, south west Nigeria.

PURPOSE: Community Pharmacists both have an important responsibility in monitoring the ongoing safety of medicines and are widely accessible to do it. This study aims to investigate the knowledge, per...

Pharmacovigilance and biosimilars: considerations, needs and challenges.

Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been a...

Feasibility of a nursing rehabilitation guideline for patients with stroke: evaluating the use by nurses.

Purpose: To determine the feasibility of the Clinical Nursing Rehabilitation Stroke-guideline (CNRS-guideline) in the care of stroke patients in terms of the experiences, views and attitudes of nurses...