10 of the Most Read Articles on Acorn Regulatory’s Website
Over the course of the year we have been highlighting some of the 100 most read articles on the Acorn Regulatory website. Again, we are featuring another 10 of the top 100 most read articles on this website. These articles have been clicked on and read thousands of times.
You can click on the headline to read the article in full or you can click here to read and see the full list of the top 100 articles on our website.
1. Type I Variation: Apparently Not So Simple
Regulatory professionals would generally perceive the Type I variation as a fairly simple regulatory procedure. New figures released by the EMA suggest differently. Statistical data released by the EMA has revealed that 44% of all Type I variation applications received for assessment by the EMA contain errors. It is reasonable to assume that these figures are mirrored for National and MRP variations. The figure of 44% is quite high when you consider that the variations classification guideline for Type I variations is quite detailed. The pharmaceutical industry is always pursuing initiatives to achieve “perfection” in our processes. This lean approach increases efficiency, improves quality and achieves what the Pharmaceutical industry is primarily focused on, providing safe and effective medicinal products to the public. The function of Regulatory Affairs is no different. Identifying areas of improvement and increasing “Right First Time” is a goal of all regulatory personnel. This article details the common deficiency areas with the idea of promoting awareness.
2. Acorn Regulatory Takes Part in Grant Thornton Docklands 5K
2 teams from Acorn Regulatory took part in the 2017 Grant Thornton 5K challenge in the Dublin Docklands.
The event saw 5000 runners of all abilities take to the streets of the Dublin Docklands to run 5KM. The 5K challenge has been an annual event for the staff at Acorn Regulatory and this year we were delighted to be able to bring 2 teams to take part. Barbara Rossiter from Acorn Regulatory was the first from Acorn Regulatory to cross the finish line in just over 20 minutes.
3. eCTD Baseline Submissions
In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.
4. Product Information Text: Formats Suitable For Blind & Partially Sighted
Braille is an internationally recognised reading and writing system used by blind and partially sighted people. The braille alphabet consists of various arrangements of raised dots that make up each character. In accordance with European legislation, braille is required to be expressed on pharmaceutical packaging.
5. Blog: The Brexit Transition Period & The Life Sciences Sector
In this blog, Brian Cleary looks at the comments of British Chancellor Philip Hammond regarding the Brexit Transition Period.
6. Are You Ready for the Falsified Medicines Directive?
The Falsified Medicines Directive was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area.
7. Commonly Deficient Issues When Applying For A Certificate of Suitability (CEP)Acorn Regulatory Opens New UK Office
The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website.
8. Moving EU Authorised Representative
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider changing EU Authorised Representative soon to ensure that you have representation with the European Union once the UK leaves the European Union.
9. 5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
10. 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 audit of the EudraVigilance database. Ad interim, the adverse reaction reporting is based on the provisions set out in Article 2(4), Article 2(5) and Article 2(6) of Directive 2010/84/EU and in line with national legislation and guidance where applicable. This is referred to as the so-called ‘Interim period’ which continues to be in place.
We will look back at further articles in the Top 100 as 2018 goes on. Don’t forget that you can look at the entire list here. If there is a topic that you would like to see covered then please let us know by completing the form below.