Acorn Regulatory’s pharmacovigilance and medical teams work with some of the largest and most dynamic companies in the world. They have looked at the major issues impacting their clients at the moment and have created ‘PV Update’ which is our latest PV e-book.
‘PV Update’ considers issues such as:
- An overview of post authorisation safety studies
- The role of the QPPV after Brexit
- What will a UK PSMF look like?
- The increasing obligations of scientific literature
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 ‘Regulatory Intelligence 7’ from Acorn Regulatory
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?
Regulatory Intelligence 6
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
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
