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...
Regulatory Affairs Case Study – Moving to OTC
Every day we work with some of the world’s biggest and most dynamic healthcare companies in the pharmaceutical and medical device sectors. Our team has a well deserved reputation for service excellence and their ability to successfully manage the most...
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...
Brexit Whitepaper No. 4 – What’s Next? – Download It Here
In our 4th Acorn Regulatory Brexit whitepaper entitled ‘What’s Next’ we focus on the results of our extensive Brexit survey. We look at our survey respondents favoured locations for the EMA, the future of the MHRA and much more.
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...
Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
In this article we look at the five things that you need to know when considering virtual wholesaling.
Outsourcing eCTD in 2019 – Is This The Right Time?
We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the airline industry. In particular, companies should consider outsourcing eCTD projects.
The eCTD Deadline is Looming: Are You Ready?
For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with client deadlines every day. However, the new deadlines that are causing the most unease in the life sciences sector are...
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...
