In Case You Missed It – Articles from the Acorn Regulatory Archive

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 second edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as DCP Close Out’s, medicinal product labelling, this year’s hot topic of GDPR and pharmacovigilance KPI’s.

10 Questions To Consider When Moving from A DCP Close Out To Product Launch

For many companies bringing a product to market, the biggest issue to contend with is the matter of finalising the regulatory procedure.  However, for small and medium life science companies that might not have a presence in a particular market, this is not the biggest issue.  The matter of completing national phases in each country and registration with the local health authorities can prove to be difficult and can significantly delay the launch of a product. Read more here.

An Overview of Medicinal Product Labelling

Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label have in common?  They all aim to provide us with information about the associated product. Read more here.

GDPR & Life Science Companies – 8 Things You Need To Know

The introduction, on May 25th 2018, of the General Data Protection Regulation (GDPR) presents a particular challenge for the life science community.  The regulation is being implemented to better protect the privacy of consumers data and, as such, there is a concern from within industry that it will stifle developments in medical science.  Nevertheless, the topic is one that all professionals within the life sciences sector need to be fully aware of as we move towards the implementation of the new regulation. In this overview, written by Acorn Regulatory’s Quality Systems Specialist Mandy Cashman we look at the main issues relating to GDPR from the perspective of the consumer and the client.  Read more here.

PV KPI’s: Pharmacovigilance Key Performance Indicators – An Overview

Our expert team has many years experience of working with clients to ensure that their pharmacovigilance systems are continuously improving.  In this blog we look at PV KPI’s and the steps that your company can take. Key performance indicators (KPI) are a set of quantifiable measures that a company uses to gauge its performance over time. These quantifiable measures can be used to indicate how a well a pharmacovigilance system is performing and whether the system is continually improving. The demands on a PV system vary depending on number of products concerned, the nature of the products and the life cycle and regulatory demands placed on the products. Read more here. We will feature many more articles from our archive as the #ICYMI  In Case You Missed It series progresses.  Feel free to share any articles of interest by using any of the links below.