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
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
- What You Need To Know About MRP Grouped Variations
