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The Acorn Regulatory Newsletter is read by life science professionals around the world every month.  We cover the stories that impact on pharmaceutical and medical device regulations.  The Acorn Regulatory newsletter keeps you up to date with what is happening at the company and in the wider industry.  Each month, we highlight the latest articles and blog posts written by our expert staff and we also highlight ‘how to’ articles from our extensive online archive of regulatory, pharmacovigilance, quality and clinical articles. Developments that will impact the sector such as Brexit, the introduction in May 2020 of the new medical device regulations, the falsified medicines directive and much more are covered regularly by our team of specialists in the newsletter. You can subscribe to the newsletter by completing the form below. [ninja_form id=8] We will never share your details with any third parties.

Read some of our past editions

You can read some of our most recent newsletters here:

Recent Publications from Acorn Regulatory

What Happens Next?

Our ‘no deal’ whitepaper takes a look at the likelihood of a ‘no deal’ Brexit and how that will impact on the life science sector. Our pharmacovigilance team look at the measures that companies need to put in place now if they are to prepare for the UK leaving the EU without a deal.  The role of the QPPV has been much discussed in recent years, since the outcome of the referendum became known, and companies need to be aware of the implications that Brexit will have on that role. The medical devices team look at the role of the EU Authorised Representative and the implications for Notified Bodies.  The devices sector is in a particular ‘state of flux’ at present with the introduction of new legislation and Brexit adds to the issues that device manufacturers need to be mindful of at this time.  Download it here.

Deadline 2020 – Are You Ready?

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied.  Download it here.

Regulatory Intelligence 5 

In this edition we look at the following topics:

• Pharmaceutical Development for Historic Dossiers
• Good Pharmacovigilance Practice (GvP) & Social Media
• The EU MDR & The Authorised Representative
• Advice for Companies Attending Scientific Advice Meetings

and

• What You Need To Know About MRP Grouped Variations

Download it here.