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.
Brexit Case Studies: Are You Prepared?
The UK’s decision to leave the European Union will have a significant impact on life science companies in Europe. Companies need to start preparing now to ensure that disruption to their business is minimised once Brexit happens. We can help....
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...
SWOT Analysis of Ireland’s Bid for the European Medicines Agency
Dublin is regarded as the most likely city to host the European Medicines Agency in our first ever Brexit survey. In this blog post we look at Dublin and carry out a brief SWOT analysis of its capacity to host...
EU Parliament Adopts New Diagnostics and Medical Device Regulations
The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th, 2017). The long-awaited final vote is the last step in an almost 8-year...
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...
Brexit: Relocation of the European Medicines Agency
The triggering of Article 50 has caused the thoughts of many to turn to the issue of the relocation of the European Medicines Agency. In this blog update we look at the countries that have joined the race to host...
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.
eCTD Deadline: Are You Ready?
The electronic Submission (eSubmission) roadmap has introduced very strict milestones for the mandatory use of eCTD format. Are you aware of the deadlines that have passed or the deadlines that are approaching? So, What does the eSubmission roadmap entail? The...
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.
