Steering a PV System: Masterclass for Heads of PV
Run the PV system on a yearly cycle of review, audit, correction and planning
Build a PV risk register and a management review that leads to decisions
Decide what to outsource and steer partners and vendors with performance data
Plan headcount and budget and defend both with figures in front of management
Pharma
Online
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Programmpunkte
09:00 Kick-off: the state of your PV system in three sentences
Participants' systems, size and recent audit or inspection experience
The running case for the day: a mid-sized MAH after a portfolio acquisition
09:30 Module 1 – The PV system as a management cycle
Quality objectives, risk register and the annual plan
Which processes really need an SOP, and how detailed it has to be
Absorbing change: new legislation, acquired products, new markets
10:30 – 10:45 Break
10:45 Module 2 – Measuring the system
Compliance and quality KPIs with thresholds and owners
Reading trends over twelve months
The management review: agenda, minutes and decisions that are followed up
11:45 Workshop 1 – Build the risk register
Groups rate the running case's PV risks and agree on three priorities for the year
12:30 – 13:15 Lunch break
13:15 Module 3 – Audits, deviations and CAPA as one loop
Risk-based audit planning under Art. 13 of Implementing Regulation (EU) No 520/2012 as amended
Deviation trending and root cause analysis
Effectiveness checks that show whether a CAPA worked
14:15 Module 4 – Outsourcing and partner steering
Make or buy: which PV activities to outsource and which to keep in-house
Service level agreements, performance reviews and exit plans
Licence partners after a product transfer: who reports what
15:00 – 15:15 Break
15:15 Module 5 – Resources and people
Calculating headcount from case volume and portfolio
A budget request management can approve, and written escalation when it is refused
Building and keeping a PV team
16:00 Workshop 2 – Five minutes in front of the board
Participants present the running case's PV status to a simulated management board
16:25 Takeaways
16:30 End of the seminar
Details
About this Workshop
Heads of PV and experienced QPPVs know the rules. The hard part is running the system: keeping procedures, audits, partners and people in step with a portfolio that keeps changing, and getting management to fund what the system needs. This masterclass deals with that work and assumes the legal basics of the QPPV role are known. The day follows the management cycle of a PV system, using one running case: a mid-sized marketing authorisation holder that has just acquired a product portfolio. Participants set quality objectives and build a risk register, choose the KPIs that belong in a management review, link audits, deviations and CAPA into one loop, and decide which activities to outsource and how to steer the partners involved. The last module covers headcount, budget and the team itself. The amended Implementing Regulation (EU) No 520/2012 comes in wherever it changes the work. Two workshops keep the day practical: groups build the risk register for the case and present its PV status to a simulated management board. The seminar is led by a practitioner who heads a global PV function and holds the EU QPPV role. It is held online in English. Participants should have experience of running a PV system or a PV team.
Plan the year
Set quality objectives, keep a PV risk register and turn both into an annual plan that can absorb new legislation, acquired products and entry into new markets.
Measure what matters
Select KPIs with thresholds and owners, read their trends over the year and run a management review whose decisions are recorded, assigned and followed up.
Close the loop
Connect risk-based audits, deviation trends and CAPA so that effectiveness checks show whether a problem has really been fixed and stays fixed across the system.
Secure resources
Calculate headcount from workload, make outsourcing decisions you can justify to an inspector and present a budget request that management can approve.
Heads of Pharmacovigilance and PV team leads
EU QPPVs and deputies with management responsibility
Local QPPVs who head a national PV unit
PV quality and compliance leads
Service providers who run PV systems for several marketing authorisation holders
Managers taking over a PV function after a merger or acquisition
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.
0127PPV602
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
21.01.2027
Referent:in
Reinhold Schilling, M.D.R.A.
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