Pharmacovigilance Basics: How Drug Safety Works in the EU
Understand why pharmacovigilance exists and who sets the rules in the EU
Recognise a valid safety case and the special situations that must be documented
Take a case from day 0 to EudraVigilance, including MedDRA coding and causality
See how signals, PSURs, RMPs and inspections build on the single case
Pharma
Online
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Programmpunkte
09:00 Welcome: where does your job touch drug safety?
Introductions and a short entry quiz
09:15 Module 1 – Why pharmacovigilance exists and who sets the rules
Thalidomide, rofecoxib and what each withdrawal changed for companies
EMA, PRAC, the European Commission and national authorities such as BfArM and PEI
Directive 2001/83/EC, Regulation (EC) No 726/2004, Implementing Regulation (EU) No 520/2012 and the GVP modules
Finding the current legal text in EUR-Lex
10:30 – 10:45 Break
10:45 Module 2 – What counts as a safety case?
Adverse event, adverse reaction, seriousness and expectedness against the SmPC
The four minimum criteria for a valid report
Special situations: pregnancy, off-label use, overdose, misuse, medication errors, lack of efficacy
When a quality complaint becomes a PV case
11:45 Workshop 1 – Case or no case?
Participants sort short reports from phone calls, e-mails and social media
Debrief: valid, not valid, or a special situation to document
12:30 – 13:15 Lunch break
13:15 Module 3 – From day 0 to EudraVigilance
When the clock starts and why every colleague must forward reports
Follow-up and reconciliation with complaints and medical information
MedDRA basics: hierarchy and coding in the reported language
Causality assessment and E2B(R3) submission deadlines
14:15 Workshop 2 – Code it and assess it
Coding verbatim terms with the MedDRA hierarchy
Writing a short causality comment for one case
15:00 – 15:15 Break
15:15 Module 4 – From the single case to the bigger picture
Signals: where they come from and how a decision is documented
PSUR, risk management plan and DHPC at a glance
The PV system: SOPs, PSMF, QPPV and Stufenplanbeauftragter, inspections and typical findings
16:00 Final quiz and next steps
Ten questions, solved and discussed together
Roles and career paths in pharmacovigilance
16:30 End of the seminar
Details
About this Workshop
Anyone who works for a pharmaceutical company sooner or later comes into contact with drug safety: a patient calls about a side effect, a complaint mentions a rash, a sales representative hears about a hospital admission. What happens in the first hours is governed by detailed EU rules, and mistakes made there are hard to repair later. This one-day seminar gives newcomers a practical grounding in pharmacovigilance. The morning explains why the field exists, using the drug withdrawals that shaped it, and introduces the authorities and the legal framework. The core of the day is the individual case: what makes a report valid, which special situations count, and how a case is coded in MedDRA, assessed and submitted to EudraVigilance on time. The last module shows how signals, periodic reports, risk management plans and inspections grow out of single cases. Two workshops let participants sort real-life reports and work through one case themselves. The seminar is led by a practitioner who heads a global pharmacovigilance department and acts as EU QPPV. No previous PV knowledge is needed. It is held online in English and ends with a short quiz. Participants who later take on oversight responsibility can continue with the seminar on the EU QPPV role.
Know the framework
Explain why pharmacovigilance exists, which EU and national authorities are involved, and where to find the laws and GVP modules that apply to your work.
Spot a valid case
Recognise the four minimum criteria and the special situations, and decide quickly whether a phone call, e-mail or post has to be forwarded and documented.
Process a case
Know when day 0 starts, code a case in MedDRA, write a causality comment that others can follow and meet the deadlines for submission to EudraVigilance.
See the system
Understand how signals, PSURs, risk management plans and the PSMF build on single cases, and which typical inspection findings start with poor case handling.
New employees in pharmacovigilance and drug safety departments
Case processors, PV assistants and drug safety associates
Staff in medical information, customer service and complaint handling who receive safety reports
Regulatory affairs, quality assurance and clinical research staff with interfaces to PV
Newly appointed local contact persons for pharmacovigilance
Employees of service providers entering the PV field
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.
0227PPV603
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
22.02.2027
Referent:in
Reinhold Schilling, M.D.R.A.
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