Acorn Regulatory News Roundup December 2016

In Acorn Regulatory News for December 2016 we are looking back at five of the stories over the past month that have caught your attention on our website and through our social media channels. We will look at the new EMA guidelines on first-in-human trials, our latest whitepaper and more.  Remember that you can click the headline on any story to be taken straight to the story and don’t forget to subscribe to our monthly newsletter by completing your details below.

1. Applying for a Marketing Authorisation – The Initial Steps

In this blog we look at the initial steps that need to be taken when applying for a marketing authorisation for a pharmaceutical product within the EEA.  This blog focuses on the application process with national authorities. Read more here.

2. Download our WDA Whitepaper

The WDA process is complex.  Indeed, many companies turn to us to manage the application process on their behalf. In our Wholesale Distribution Authorisation Whitepaper, 5 Steps To Obtaining A Wholesale Distribution Authorisation, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence. Read more here.

3. Regulatory Affairs Consultant Vacancy – Join Our Team!

Right now we have a Regulatory Affairs Consultant vacancy in our pharmaceutical team and we are interested in speaking to candidates with an interest in developing their career with one of Europe’s leading regulatory affairs consultancy firms. Read more here.

4. How Will The UK Life Sciences Sector Address Post Brexit Skills Shortages

The UK pharmaceutical sector employs in excess of seventy thousand people. The structure of a Brexit will have significant impact on them and the industry that they work in. For now, there is a firm belief that the UK will make a full exit from the single market and, with that, there will be restrictions on those seeking to move to the UK. How will the UK handle post Brexit skills shortages? Read more here.

5. EMA Guidelines on First in Human Trials Revised

The EMA guidelines on first in human clinical trials have been revised.  The European Medicines Agency issued its proposed revisions to the 2007 guideline in mid November.  Read more on Acorn Regulatory News about the revision of the guidelines.  Read more here.

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