The EU Qualified Person for Pharmacovigilance (EU QPPV)
Legal foundations, core responsibilities, and practical application
- In-depth understanding of the legal framework for the EU QPPV
- Practical insights and interactive workshops
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
Ab
2.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 2.090,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
Buchungsdetails
Online-Seminar
Ab
2.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 2.090,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
This comprehensive two-day online course equips aspiring and practising QPPVs with the regulatory knowledge and practical skills needed for effective oversight and ongoing compliance.
Your speakers
Dr. Tanja Peters
Bavarian Nordic GmbH
Head Global Clinical Safety and Pharmacovigilance, EU/UK QPPV;
Dr Peters is a clinical pharmacologist with over 25 years’ experience in the pharmaceutical industry across Research…
Your speaker
Dr. Tanja Peters
Bavarian Nordic GmbH
Head Global Clinical Safety and Pharmacovigilance, EU/UK QPPV;
Dr Peters is a clinical pharmacologist with over 25 years’ experience in the pharmaceutical industry across Research and Development, Regulatory Affairs and Pharmacovigilance, having held roles at Boehringer Ingelheim, Merck KGaA and Bavarian Nordic. As Deputy EU QPPV and Head of PV Intelligence at Boehringer Ingelheim, she implemented EU GVP and the global PSMF, and, in collaboration with regional PV organisations, established a PV intelligence network to analyse emerging pharmacovigilance requirements and translate them into local and global PV systems. Within Medical Safety, she championed the development of signal management, risk management and safety communications. She is particularly passionate about coaching and developing early-career talent. Dr Peters currently serves as Head of Global Drug Safety and EU/UK QPPV at Bavarian Nordic.
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG
Head of Global Pharmacovigilance, EU-QPPV, and local QPPV;
Reinhold Schilling is a recognised expert in the field of pharmacovigilance, with over a decade of experience in…
Your speaker
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG
Head of Global Pharmacovigilance, EU-QPPV, and local QPPV;
Reinhold Schilling is a recognised expert in the field of pharmacovigilance, with over a decade of experience in drug safety and regulatory requirements. Holding dual master's degrees in Chemistry and Drug Regulatory Affairs, he has been heading the global drug safety department of Wörwag Pharma GmbH & Co. KG as Head of Global Pharmacovigilance since 2021. In addition to his work in industry, Reinhold Schilling is also active in academia, serving as a lecturer in pharmacovigilance at Reutlingen University and at the Goethe Business School. As an active member of the BPI Pharmacovigilance Working Group, he contributes his expertise to the further development of regulatory frameworks.
What to Expect
- Legal framework, liability, and legal protection
- Regulatory requirements for day-to-day practice
- Maintaining oversight of your pharmacovigilance system
- Specific tasks, responsibilities, and possible delegations
- Ensuring compliance
Who Should Attend
This course will be conducted in English.
This course is designed for professionals with a basic understanding of pharmacovigilance who are aspiring to become (EU) QPPVs or serve as their deputies. It is also ideal for part-time QPPVs or anyone seeking a concise, high-impact refresher. While you do not need to be a QPPV to benefit from this course, a fundamental knowledge of pharmacovigilance is essential.
Objective of the Event
The Qualified Person for Pharmacovigilance (QPPV) holds a pivotal role for every Marketing Authorisation Holder (MAH) in the EU, carrying significant responsibility and a wide range of duties.
This course provides concise and practical guidance on the QPPV's responsibilities, grounded in the relevant legal framework. Upon completion, you will have a clear understanding of the expectations and regulatory obligations associated with this role, and you will be equipped to apply this knowledge confidently in your daily work. Real-life case studies, practical exercises, and interactive workshops will help you to successfully transfer what you have learnt into professional practice.
Your Benefit
This online course will...
- familiarise you with the role, responsibilities, and legal obligations of a QPPV in the EU.
- guide you on how to maintain oversight of your pharmacovigilance system.
- enable you to delegate QPPV responsibilities appropriately.
- provide you with an online test to validate your knowledge, leading to a certificate of completion.
Programme
09:00 - 17:00 CET Both days
You may join 30 min before the session starts
Day 1
08:45 - 09:00
You are welcome to log in early to test your audio and video settings before the event begins.
09:00
FORUM Institut
09:15
Reinhold Schilling
- System overview
- Directives and regulations
- Good Pharmacovigilance Practices (GVP)
10:45
11:00
Dr Tanja Peters
- Relevant directives and regulations
- GVP Modules
- QPPV roles in other regions (e.g. EAEU, Arab countries)
- EU QPPV vs national Responsible Person for Pharmacovigilance
12:00
Reinhold Schilling
- Can you identify the responsibilities outlined in GVP Modules I, II, and VI and correctly assign them to either the Marketing Authorisation Holder (MAH) or the EU QPPV?
12:30
13:30
Reinhold Schilling
- Safety variations
- PSUSA procedures
- EURD List, PBRER/PSUR scheduling and submission
- RMP creation
- Educational material
- Market research
- Social media
- Contract management
15:00
15:15
Both speakers
- How can you design an effective flow chart for the core pharmacovigilance task of processing adverse events and reactions?
16:15
Dr Tanja Peters
16:45
Both speakers
17:00
08:45 - 09:00
Technical warm-up
Technical warm-up
You are welcome to log in early to test your audio and video settings before the event begins.
Start of the seminar: Welcome and introduction
09:15
The pharmacovigilance system: Overview and legal foundations
The pharmacovigilance system: Overview and legal foundations
Reinhold Schilling
- System overview
- Directives and regulations
- Good Pharmacovigilance Practices (GVP)
Coffee break
11:00
Legal framework for the EU QPPV
Legal framework for the EU QPPV
Dr Tanja Peters
- Relevant directives and regulations
- GVP Modules
- QPPV roles in other regions (e.g. EAEU, Arab countries)
- EU QPPV vs national Responsible Person for Pharmacovigilance
12:00
Workshop: Responsibilities within the pharmacovigilance system
Workshop: Responsibilities within the pharmacovigilance system
Reinhold Schilling
- Can you identify the responsibilities outlined in GVP Modules I, II, and VI and correctly assign them to either the Marketing Authorisation Holder (MAH) or the EU QPPV?
Lunch break
13:30
Routine pharmacovigilance activities
Routine pharmacovigilance activities
Reinhold Schilling
- Safety variations
- PSUSA procedures
- EURD List, PBRER/PSUR scheduling and submission
- RMP creation
- Educational material
- Market research
- Social media
- Contract management
Coffee break
15:15
Workshop: Case processing
Workshop: Case processing
Both speakers
- How can you design an effective flow chart for the core pharmacovigilance task of processing adverse events and reactions?
Key Tasks of the EU QPPV
Discussion and Q&A session
End of Day 1
Day 2
09:00
Both speakers
09:15
Reinhold Schilling
- GVP Module XV
- Labelling and package leaflet
- Direct healthcare professional communication (DHPC)
- Educational material
10:45
11:00
Dr Tanja Peters
- Legal basis and GVP Modules IX, V, and XVI
- Product overview
- Identifying, assessing, and presenting signals
- PRAC examples
11:45
Reinhold Schilling
- Standard operating procedure (SOP) or work instruction (WI)
- Master SOP
- SOP administration
- Exercise: SOP creation using the Master SOP
12:30
13:30
Dr Tanja Peters
- Key components and processes of the PV quality system
- Establishing compliance structures and ensuring continuous monitoring
- Training requirements
- Documentation and archiving
14:15
Reinhold Schilling
- KPI basics: From mandatory to optional
- Exercise: Quantitative and qualitative KPIs
- Tracking and dashboard reporting
15:00
15:30
Dr Tanja Peters
- Legal framework and regulatory authorities
- Regulatory expectations towards the pharmaceutical company
- Corrective and preventive action (CAPA)
16:00
Both speakers
- You have received an invitation to a local inspection - how do you prepare?
16:45
Both speakers
17:00
Start of Day 2: Wrap-up of Day 1
09:15
Communication with stakeholders and risk communication
Communication with stakeholders and risk communication
Reinhold Schilling
- GVP Module XV
- Labelling and package leaflet
- Direct healthcare professional communication (DHPC)
- Educational material
Coffee break
11:00
Signal detection and risk management
Signal detection and risk management
Dr Tanja Peters
- Legal basis and GVP Modules IX, V, and XVI
- Product overview
- Identifying, assessing, and presenting signals
- PRAC examples
11:45
SOP management
SOP management
Reinhold Schilling
- Standard operating procedure (SOP) or work instruction (WI)
- Master SOP
- SOP administration
- Exercise: SOP creation using the Master SOP
Lunch break
13:30
PV quality management and compliance
PV quality management and compliance
Dr Tanja Peters
- Key components and processes of the PV quality system
- Establishing compliance structures and ensuring continuous monitoring
- Training requirements
- Documentation and archiving
14:15
KPI creation and measurement
KPI creation and measurement
Reinhold Schilling
- KPI basics: From mandatory to optional
- Exercise: Quantitative and qualitative KPIs
- Tracking and dashboard reporting
Coffee break
15:30
Audits and inspections
Audits and inspections
Dr Tanja Peters
- Legal framework and regulatory authorities
- Regulatory expectations towards the pharmaceutical company
- Corrective and preventive action (CAPA)
16:00
Workshop: Inspection readiness
Workshop: Inspection readiness
Both speakers
- You have received an invitation to a local inspection - how do you prepare?
Discussion and Q&A session
End of the seminar
Downloads
Request the documents using our form.
Brochure
Brochure: Qualification Course Head of Pharmacovigilance
Brochure: Qualification Course Qualified Person for Pharmacovigilance (QPPV)
Abbreviation list Pharmacovigilance
Further Informations
An interactive seminar with learning assessment and certificate
This course combines solid theoretical foundations with hands-on workshops and lively, interactive discussions. To help you get the most out of the online format, we kindly ask you to keep your camera on whenever possible and to participate actively in the discussions.
After the seminar, you may complete a multiple-choice test in our Learning Space to demonstrate your learning progress. All participants will receive a certificate of attendance. If you pass the test, you will also receive an additional certificate confirming successful completion of the course "The EU Qualified Person for Pharmacovigilance (EU QPPV)".
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
This is what distinguishes this event
The overall impression of the event was rated 4.0/5 stars.
(June 2026)
The event materials were rated 4.3/5 stars.
(June 2026)
Customer Testimonials
What satisfied participants say
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Further Information
Checklist for Medical Writing in PV
Necessary PV documents, contents and a medical writing checklist as a short overview.
In-house seminars
Our programmes are also available for in-house training. Just contact us!
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de