Acorn Regulatory Takes Part in Enterprise Ireland & IDA Trade Mission Events
Acorn Regulatory staff took part in a number of the Enterprise Ireland & IDA Trade Mission to Ireland events in Dublin and Cork yesterday. The purpose of the trade mission was to facilitate networking opportunities between Enterprise Ireland clients (of which Acorn...
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...
SWOT Analysis of the Barcelona Bid for the European Medicines Agency
As inducements go, few are as tempting as the Torre Agbar in Barcelona. The iconic Catalan skyscraper has been offered to the European Medicines Agency should they wish to choose Barcelona as their next home. Until recently, the Spanish city...
SWOT Analysis of the Copenhagen Bid for the European Medicines Agency
Copenhagen is a significant contender to host the European Medicines Agency. In this blog post we look at Copenhagen and carry out a brief SWOT analysis of its capacity to host the EMA.
Blog: What Is The MHRA Quiet Period?
In this blog Brian Cleary answers the questions that many people are asking; what is the MHRA quiet period and why does it exist?
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitEU Authorised RepresentativeIVD DevicesMDD DevicesMedical Devices
10 Responsibilities of a EU Authorised Representative
The responsibilities and role of the EU Authorised Representative (or EUAR) is now in the spotlight as a result of the UK’s decision to leave the EU. Many companies have previously chosen EU Authorised Representatives from the UK and, as...
Blog: The European Medicines Agency & The EU Brexit Summit
In this Acorn Regulatory blog, Brian Cleary looks ahead to the EU Brexit Summit and the news that the relocation of the EMA will incur a significant fee for the London offices of the agency.
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....
