The EU QPPV Role: Oversight in Daily Practice
Know what the law demands of the QPPV personally and what stays with the MAH
Delegate PV tasks to staff, partners and vendors and keep oversight
Build an oversight routine around the few metrics and records that matter
Prepare for the QPPV interview in an inspection and name your evidence
Pharma
Online
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Programmpunkte
09:00 Welcome: why did you take on the role, or why are you about to?
Expectations and the questions participants bring to the day
09:15 Module 1 – The role in law and in GVP
Art. 104 of Directive 2001/83/EC, Implementing Regulation (EU) No 520/2012 and GVP Modules I and II
Requirements: natural person, EEA residence, qualification, 24/7 availability and back-up
What the MAH owes the QPPV: authority, resources and access to information
Changes from Implementing Regulation (EU) 2025/1466 that touch the QPPV's daily work
10:30 – 10:45 Break
10:45 Workshop 1 – Who owns what?
Participants sort duties between MAH, QPPV, deputy and local contact persons
Discussion of the grey zones: responsibility, oversight and execution
11:30 Module 2 – Oversight of the core processes
Case processing: compliance rates, late cases and reconciliation as oversight evidence
Signals: what the QPPV must see before a signal is closed
PSURs and RMPs: what the QPPV reviews before sign-off, and how to document it
12:30 – 13:15 Lunch break
13:15 Module 3 – Delegating to people, partners and vendors
Job descriptions, delegation records and a deputy who can really step in
Licence partners and service providers: agreements, performance data and audits
National contact persons in other EU countries and beyond, in brief
14:15 Module 4 – The QPPV's oversight routine
A monthly review with a small set of KPIs
What belongs in the PSMF and its logbook, and who keeps them current
Escalating to management in writing
15:00 – 15:15 Break
15:15 Workshop 2 – The QPPV interview
Role play: participants answer typical inspector questions
Feedback: evidence named, oversight shown, nothing guessed
16:00 Your first 100 days as EU QPPV
A starter checklist and final discussion
16:30 End of the seminar
Details
About this Workshop
Every marketing authorisation holder in the EU needs a QPPV: one person, resident in the EEA, reachable around the clock and responsible for overseeing the whole pharmacovigilance system. The legal text on the role is short, a few paragraphs in law and guidance. In practice the hard questions are about oversight. Which duties stay with the company, which belong to the QPPV personally, and how does a QPPV show control over processes run by colleagues, licence partners and service providers? This one-day seminar starts from the legal basis, including the changes brought by Implementing Regulation (EU) 2025/1466, and then looks at the core PV processes through the QPPV's eyes: which figures and records show that case processing, signal management and periodic reporting are under control. The afternoon covers delegation, the QPPV's own review routine and escalation to management. Two workshops make it concrete: participants sort responsibilities between MAH and QPPV and practise the QPPV interview in an inspection. The seminar assumes basic PV knowledge, as taught in the PV basics seminar. It is led by a practitioner who holds the EU QPPV role in industry and is held online in English. Participants leave with a checklist for their first 100 days in the role.
Know the legal basis
Name the laws and GVP modules that define the QPPV role and explain what Implementing Regulation (EU) 2025/1466 changes for the QPPV in daily practice.
Separate the duties
Distinguish clearly what the MAH must provide from what the QPPV oversees, and set up delegation to staff, licence partners and vendors that stands up to scrutiny.
Oversee with evidence
Choose the metrics and records that show case processing, signals and periodic reports are under control, and review them in a fixed monthly routine with clear escalation.
Face the inspector
Answer typical questions on QPPV oversight in an inspection interview by naming concrete evidence, and start the role with a clear and realistic 100-day plan.
Newly appointed EU QPPVs and those preparing for the role
Deputy QPPVs and back-up persons
Local QPPVs and national contact persons, e.g. Stufenplanbeauftragte
Experienced pharmacovigilance staff moving into a leading role
Regulatory affairs, QA and medical affairs staff working with the QPPV
Service providers offering QPPV or PV services
Unsere Referent:innen
Reinhold Schilling, M.D.R.A.
Reinhold Schilling has headed global pharmacovigilance at Wörwag Pharma GmbH & Co. KG in Böblingen since 2021, where he is EU QPPV and Stufenplanbeauftragter. A chemist by training with a Master of Drug Regulatory Affairs, he has worked in drug safety since 2011, including earlier roles as Stufenplanbeauftragter and Informationsbeauftragter for Germany and Austria. He trains PV teams, audits PV systems and teaches pharmacovigilance at Reutlingen University and Goethe Business School. He is a member of the BPI pharmacovigilance working group.
EU QPPV in practice
Head of Global Pharmacovigilance, EU QPPV and Stufenplanbeauftragter at Wörwag Pharma GmbH & Co. KG.
Trainer and auditor
Trains pharmacovigilance staff and audits PV systems, processes and service providers.
Teaching
Lecturer in pharmacovigilance at Reutlingen University and in the Pharma MBA at Goethe Business School; member of the BPI PV working group.
Academic background
Diplom-Chemiker and Master of Drug Regulatory Affairs (M.D.R.A.), University of Bonn.
Seminar-Nr.
PPV603
Schnellübersicht
Alle wichtigen Infos auf einen Blick
Dauer
7,5 Stunden (9:00–16:30 Uhr)
Format
Online
Preis
390 EUR (zzgl. gesetzl. USt)
Nächster Termin
13.05.2027
Referent:in
Reinhold Schilling, M.D.R.A.
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