This month in the October 2018 newsletter we are looking at issues such as Scientific Advice Meetings, the updated CMC guidelines and much more.
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In this article, we look at the issue of Scientific Advice Meetings. This is 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 meetings including the growth in the number of meetings being held annually and what your company can do to prepare for a Scientific Advice Meeting. Read more here.
Acorn Regulatory Shortlisted for TOPRA Award
Acorn Regulatory has been shortlisted for a prestigious TOPRA Award at the annual regulatory excellence awards.
This is the fourth nomination that the company has received for TOPRA’s Regulatory Excellence Awards.
Read more here.
Speakers from Acorn Regulatory were among the speakers at this year’s annual RQA (The Research & Quality Association) conference in Dublin on October 11th 2018.
Acorn Regulatory’s Gemma Robinson and Brian Cleary presented on the topic of ‘Brexit: Current Agreements & Implications for the Pharmaceutical and Medical Device Industry’. They were joined by speakers from Agilent, Almac, Roche Ireland and the HPRA.
Read more about the presentation here.
Are you aware of the changes made to the guidelines on the manufacture of the finished dosage form? We have an overview that will assist you.
The updated CMC guidelines on the manufacture of the finished dosage form, CHMP/QWP/486/95, first issued in April 1996, were updated and the new version, EMA/CHMP/QWP/245074/2015, were made effective in February 2018.
Read more here.
The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. For many, the issue of Brexit has ‘muddied the water’ somewhat. Anecdotal evidence would suggest that there has been a large increase in the number of companies seeking WDA’s from the HPRA in Ireland. Read more and download the free e-book here.
Brexit continues to occupy the thoughts of professionals in the regulatory and in the wider life sciences sector. The UK’s path to the exit has been fraught with difficulty. Now, as the UK enters into its final months as an EU member state, we want to keep you informed of the Brexit issues that relate to the regulatory and life science sectors.
We are creating a limited run series Brexit newsletter that will aim to inform professionals in the regulatory and wider life sciences sector. Each month, between September 2018 and March 2019, we will analyse the impact of Brexit on the sector.
Much has been written about the benefits of smart packaging for the pharmaceutical sector. The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging and consider the benefits that it might bring to our sector. Read more here.
Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this third edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as simplified adverse event reporting, the code of practice for IPHA and the ABPI, Ireland’s location as a clinical trial location and the eSubmission roadmap. Read more here.
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