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HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes
Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection and advertising compliance programmes that was held at the Hilton Dublin on November 27th 2017.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
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...
What’s New in Pharmacovigilance? Get Our E-Book
Our latest pharmacovigilance e-book looks at PSUR’s, key performance indicators and more. Download the free e-book here.
Download: WDA Whitepaper – 5 Steps To Obtaining A WDA (A Wholesale Distribution Authorisation)
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. In our updated WDA whitepaper, 5 Steps To Obtaining A Wholesale Distribution Authorisation, we have highlighted 5 steps that companies must...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitGemma RobinsonMarketing Authorisation Holders
Brexit: Implications on Existing Marketing Authorisations
One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceutical
Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
eCTD Baseline Submissions
In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.
Brexit: One Year On – The 5th Acorn Regulatory Whitepaper
Brexit: One Year On is the 5th Acorn Regulatory whitepaper. In this edition we look at some of the most pressing issues for regulatory specialists such as the changes to marketing authorisations, the need to move EU Authorised Representatives and...
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...
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