Will Clinical Trials Be Impacted By Brexit?
How will clinical trials be impacted by the UK’s decision to leave the European Union? The United Kingdom’s decision to leave the European Union (EU) will present significant implications to the pharmaceutical industry. Clinical trial sponsors and associated partners should...
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EU Authorized Representative – Find Out What You Need To Know As Brexit Nears
In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK and into another EU country. Companies with an EU Authorized Representative in the UK have been forced to appoint a...
The Increasing PV Obligations of Scientific Literature
Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
Interpreting the CEP (Certificate of Suitability) Monograph
The issue of CEP’s (Certificate of Suitability) arises on a frequent basis. We have extensive experience of assisting companies in obtaining CEP’s. In this article we provide an update on what is needed for a CEP application.
2018’s Most Read Pharmaceutical Articles from Acorn Regulatory
In our end of year series we are looking at the most widely read articles on our website. This week we are looking at the most read pharmaceutical articles written by our pharmaceutical specialists. They cover a variety of areas...
Scientific Advice Meetings – Advice for Companies
Scientific Advice Meetings are an area where clients and prospective clients consistently seek our support. Our expert team has significant experience of dealing with relevant agencies for such meetings. This article looks at a number of issues related to the...
#ICYMI – Featured Articles from the Acorn Regulatory Archive
Our #ICYMI series has looked at some of the best articles that have been written by members of the Acorn Regulatory team. They also present a good opportunity to bring to your attention articles that you might not have seen...
What You Need To Know About the EU MDR & The Authorised Representative
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is...
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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...
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.
