NTK: Need To Know- 5 Pharmacovigilance Articles You Must Read
We produce hundreds of thought leadership pharmacovigilance articles on our site and in publications each year. Here are just 5 pharmacovigilance articles that you might have missed and that you should read.
Are You Ready for the Falsified Medicines Directive?
The Falsified Medicines Directive (FMD) was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area. Conformity with the FMD will be required from February 9th, 2019 next.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent...
Package Leaflets & Bridging Reports: An Overview
In our second piece in a series about package leaflets, we look at consultations with target patient groups and, in particular, bridging reports.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Do You Know Your PV KPI’s? – Find Out More About Them Here
Our expert team has significant experience of working with clients to ensure that their pharmacovigilance systems are continuously improving. In this blog, we look at PV KPIs and the steps that your company can take. We consider issues such as...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Are You Prepared for a Pharmacovigilance Inspection?
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. In this article, we look at the measures that your company can take to be...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceGemma RobinsonPharmaceuticalPharmacovigilance
Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?
Acorn Regulatory assists companies in maintaining compliance with a variety of codes of conduct. In this article, we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK and Ireland. The respective IPHA and...
Acorn Regulatory NewsAuditClinical & MedicalPharmaceuticalPharmacovigilancePublicationsQuality Management System
Download ‘Regulatory Intelligence’ from Acorn Regulatory
Our team of regulatory affairs experts is regarded as the thought leader in the sector. They have worked on some of the most challenging and groundbreaking regulatory projects in modern times. They regularly write for specialist periodicals and speak...
Find Out More About Acorn Regulatory’s Pharmacovigilance Services
Right now, we are working as the ‘virtual pharmacovigilance office’ for many of the most dynamic healthcare manufacturers in the world. They trust us to act on their behalf because of our long-held reputation and our commitment to service excellence....
EMA Introduces New Chapter on Good Pharmacovigilance Practices (EU-GVP)
The European Medicines Agency has added a new chapter (Product- or population-specific considerations II: Biological medicinal products) to its guidelines on good pharmacovigilance practices – EU GVP. The new GVP guidance comes into force on August 16th 2016. The new chapter...
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