Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesAdvertisingComplianceGemma RobinsonPharmaceutical
Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). We look at the issues relating to advertising a...
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Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
Acorn Regulatory Monthly Newsletter: September 2016
We have just launched our new Acorn Regulatory monthly newsletter. You can read all of the stories from the newsletter here. If you are not already subscribing then sign up to receive the next edition.
The Implications of Brexit for the Life Sciences Sector
The implications of Brexit are still being felt. Politically, the decision has triggered a chain of events that none of us could have ever foreseen. Now, with a new Prime Minister in Downing Street and three leading ‘Brexiteers’ appointed to offices...
Implications of Brexit for the Medical Device Sector
In this extract from our first Brexit whitepaper, written in July 2016, we look at the implications of Brexit for the medical device sector.
Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesClinical & MedicalFeatured NewsGemma RobinsonIndustry News
A Tightening of Regulations for Phase I Clinical Studies?
The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase (FAAH) inhibitors under investigation in the US. The investigation comes in the aftermath of a Phase I clinical trial in France, in which...
Medical Literature Monitoring (MLM) – Current Status
The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service. The service was launched in summer 2015, focusing on the top 50 active chemical substance groups. Since last September, the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersQuality Management SystemTraining
Conducting Internal Audits – Guidance from our Quality Team
Our quality team has a well deserved reputation for excellence. In this blog they share their thoughts on what you need to do when conducting internal audits at your facility. Guidance on conducting Internal Audits – ISO 9001:2008 ISO 9001:2008 8.2.2...
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