This edition covers the following issues:
- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
- Clinical Investigations Under MDR
- The U.K. PSMF -What Will It Look Like?
Further Reading
Recent Publications from Acorn Regulatory
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.Download the 3rd Acorn Regulatory MDR Whitepaper
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR. Our previous MDR publications have drawn considerable interest from experts in the sector. This edition is the third in the series and the first to be published in 2020. You can download your copy below. Download it here.Regulatory Intelligence 6
‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector.
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 a MAH and you are outsourcing some/all of your production
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
