Person Responsible for Pharmacovigilance

QPPV and Local Contact Person

Live online, 23 and 24 November 2022

The webinar will be held in Slovene.

Organizer: Solutiones d.o.o.

The meeting is sponsored by expert contributions from companies Billev farmacija vzhod and Clinres Farmacija.

A two-day online webinar “Responsible Person for Pharmacovigilance: QPPV and local contact person” will be organized on 23 and 24 November 2022. The presentations will be held by experts in the relevant fields. The webinar will also include two training workshops.

The training is aimed at persons responsible for collecting information and reporting on adverse drug reactions, in particular QPPVs and contact persons which work for marketing authorisation holders, subsidiaries, and distributors. The training is also aimed at other healthcare professionals involved in the reporting of adverse reactions of medicinal products.

The vast majority of the most serious pharmacovigilance events (including fatal ones) are caused by medicines or active substances of poor quality. The seminar highlights the inextricable link between the quality system, the pharmacovigilance system, the persons responsible for the quality of medicines and the importance of cooperation in the event of an emergency. As many pharmacovigilance events are closely linked to the quality of medicines, the roles of quality officers and managers will be highlighted.

Key topics

• EU pharmacovigilance system
• Pharmaceutical quality systems
• Risk management in the pharmacovigilance system
• EU QPPV
• Pharmacovigilance contact person
• Pharmacovigilance audits
• Adverse reaction reporting (in clinical studies)
• Good pharmacovigilance practice guidelines Module III – pharmacovigilance inspections

Please find more information about the event and the application form below. All documents are in Slovene.