Most Read Pharmaceutical News Stories on in 2016

The team at Acorn Regulatory has been busy all year working with our global client base.  Nevertheless, they have taken time to share their expertise on issues such as risk minimisation, the EU regulatory framework, the Periodic Safety Update Single Assessment  or PSUSA and more.  Here we have brought together the 5 most read pharmaceutical sector news stories from our website in the past year.

Click the headlines below to read each of the 5 most read medical device news stories of the past year and, if you want to receive stories like this straight to your inbox regularly, subscribe to our monthly newsletter by completing your details below.

Here are the 5 most read stories of the past year.

1. Advertising of Medicinal Products – An Overview

Earlier this year, Senior Regulatory Affairs Advisor, Dr John McIntyre produced an brief outline of the issues relating to advertising medicinal products.  He outlined the common issues and also a recent breach that led to a reprimand for an advertiser.  Read More Here.

2. Key Factors To Consider When Planning To In-Licence An eCTD Dossier

When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully.  For instance, the eCTD version specific information and tool capability is crucial to import from one system to another.  Try to ensure the version number of the DTD/specification is equal to or lower than the software you will be using in-house or else you may need to upgrade software when it comes time to submissions which may lead to unplanned extra costs. Read More Here.

3. Five 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. Read More Here.

4. Risk Minimisation Measures – Educational Material

To address risk minimisation, Healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A Risk Management Plan will include an Action Plan outlining risk minimisation activities that are carried out to reduce the probability of an adverse reaction occurring or its severity should it occur. Read More Here.

5. 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.

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