Preparing the Reference Safety Information for a Clinical Trial
What are the steps that companies need to take when preparing the reference safety information for a clinical trial? This article looks at the steps that you need to take.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersIndustry NewsMDRPharmaceuticalPharmacovigilance
How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
How Will Brexit Impact UK Marketing Authorisation Holders?
The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union. In this article we look at one of the main questions highlighted by the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
How To Develop A Regulatory Strategy: An Overview
The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market its medicinal product across regions subject...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceutical
Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
Product Information Text: Formats Suitable For Blind & Partially Sighted
Braille is an internationally recognised reading and writing system used by blind and partially sighted people. The braille alphabet consists of various arrangements of raised dots that make up each character. In accordance with European legislation, braille is required to...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
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...
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...
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