‘Regulatory Intelligence 6’ from Acorn Regulatory is the latest edition of our e-book series that looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
In edition 6 we look at:
post authorisation safety studies and how they are linked to Risk Minimisation Plans,
what you need to consider if your EU QPPV is in the UK,
the impact of Knowledge Aided Assessment and Structured Application, and
what you need to know if you are an MAH and you are outsourcing some/all of your production
Get the ‘Regulatory Intelligence 6’ e-book straight to your inbox by completing the form below.
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.
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.