The European Medicines Agency published it’s first issue of QPPV Update.

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.

The issue provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance.

Main content of it covers news regarding these topics, and what does it mean to you as someone working in Pharmacovigilance:

• “Pharmacovigilance in the product lifecycle” including: Risk Management Planning critical for patient safety and product innovation, Companies encouraged to seek scientific ad-vice for PASS, Initiative on Patient Registries.
• “Pharmacovigilance Pro-cesses” including topics such as: Quicker product information updates, Medical literature monitoring, Reliance on Article 57 data, Joint PRAC/CHMP assessment reports, Measuring the impact of pharmacovigilance activities.
• Pharmacovigilance guidance: a table that represents the latest adopted, planned, and under development guidance.
• “Pharmacovigilance IT Systems” covering: Article 57 database, EudraVigilance Auditable Requirements, PSUR Repository, Pharmacovigilance Fees.
• Pharmacovigilance dialogue about upcoming EMA events.

Download the issue here: EMA Site