In this joint webinar hosted by Fusion Pharma and ADAMAS Consulting, Leah Heathman and Sarina Norris explore The Windsor Framework and the impact to pharmacovigilance activities in the UK.
Covered in this webinar:
- A recap on the background of the Windsor Framework
- Windsor Framework measures and impact to Regulatory
- Overview of impact to artwork and supply
- Impact to Marketing Authorisations
- MHRA categorisation of products for PV purposes
- Individual Case Safety Reports (ICSR)
- Periodic Safety Update Reports (PSURs)
- Post authorisation safety studies (PASS)
- UK-specific actions
- Implementation of EU Outcomes / Safety Referrals
- UK Qualified Person for Pharmacovigilance (QPPV)
- UK Pharmacovigilance Master File (PSMF)
- Notification of QPPV and PSMF to XEVMPD
Access the webinar recording and presentation materials below:
