‘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 RegulatoryDownload it here.
- 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?
- 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
- 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