2025-06-24 2025-06-24 , online online, 2,090 € zzgl. MwSt. Dr. Tanja Peters https://www.forum-institut.de/seminar/26012052-the-eu-qualified-person-for-pharmacovigilance-eu-qppv/referenten/26/26_01/26012052-course-the-eu-qualified-person-for-pharmacovigilance-eu-qppv_peters-tanja.jpg The EU Qualified Person for Pharmacovigilance (EU QPPV)

This two-day course equips beginners with the fundamentals of EU pharmacovigilance legislation, QPPV responsibilities, and strategic planning. Learn what it takes to fulfil the role, ensure compliance, and build your roadmap to QPPV readiness. Ideal for aspiring QPPVs or those preparing future candidates. Secure your place today!

Topics
  • 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. Please note: This is an interactive virtual course with live group work and collaborative exercises. A stable internet connection and an active webcam are mandatory for participation.
Aims and objectives
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.
  • include an online test to validate your knowledge, leading to a certificate of completion.

Online course - The EU Qualified Person for Pharmacovigilance (EU QPPV)

The EU Qualified Person for Pharmacovigilance (EU QPPV)

The intensive beginner's course on legal foundations and practical application

Benefits
  • In-depth understanding of the legal framework for the EU QPPV
  • Practical insights and interactive workshops
  • Expert speakers from industry and legal practice
  • Officially certified to the ISO 9

Webcode 26012052

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Termin

27-28/01/2026

27-28/01/2026

Zeitraum

09:00 - 17:00 CET Both days
You may dial in 30 min before the session

09:00 - 17:00 CET Both days
You may dial in 30 min before the session
Veranstaltungsort

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

This two-day course equips beginners with the fundamentals of EU pharmacovigilance legislation, QPPV responsibilities, and strategic planning. Learn what it takes to fulfil the role, ensure compliance, and build your roadmap to QPPV readiness. Ideal for aspiring QPPVs or those preparing future candidates. Secure your place today!

Topics

  • 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. Please note: This is an interactive virtual course with live group work and collaborative exercises. A stable internet connection and an active webcam are mandatory for participation.

Aims and objectives

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.
  • include an online test to validate your knowledge, leading to a certificate of completion.

Detailed programme

09:00 - 17:00 CET Both days
You may dial in 30 min before the session

08:45 - 09:00

Technical warm-up
You are welcome to log in early to test your audio and video settings before the event begins.

09:00

FORUM Institut

Start of the seminar: Welcome and introduction

09:15

Reinhold Schilling

The pharmacovigilance system: Overview and legal foundations
  • System overview
  • Directives and regulations
  • Good Pharmacovigilance Practices (GVP)

10:45 Coffee break


11:00

Dr Tanja Peters

Legal framework for the EU QPPV
  • Relevant directives and regulations
  • GVP Modules I, II, and VI
  • QPPV roles in other regions (e.g. EAEU, Arab countries)
  • EU QPPV vs national Responsible Person for Pharmacovigilance

12:00

Reinhold Schilling

Workshop: Responsibilities within the pharmacovigilance system
  • 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 Lunch break


13:30

Reinhold Schilling

Routine Pharmacovigilance Activities
  • Safety variations
  • PSUSA procedures
  • EURD List, PBRER/PSUR scheduling and submission
  • RMP creation
  • Educational material
  • Market research
  • Social media
  • Contract management

15:00 Coffee break


15:15

Both speakers

Workshop: Case processing
  • How can you design an effective flow chart for the core pharmacovigilance task of processing adverse events and reactions?

16:15

Dr Tanja Peters

The specific tasks of an EU QPPV

16:45

Both speakers

Discussion and Q&A session

17:00 End of Day 1


09:00

Both speakers

Start of Day 2: Wrap-up of Day

09:15

Reinhold Schilling

Communication with stakeholders and risk communication
  • GVP Module XV
  • Labelling and package leaflet
" Direct Healthcare Professional Communication (DHPC)
" Educational Material

10:45 Coffee break


11:00

Dr Tanja Peters

Signal detection and risk management
  • Legal basis and GVP Modules IX, V, and XVI
  • Product Overview
  • Identifying, assessing, and presenting analyzed signals
  • PRAC examples

11:45

Reinhold Schilling

SOP Management
  • Standard Operating Procedure (SOP) or Work instruction (WI)
  • Master SOP
  • SOP administration
  • Exercise: SOP creation using the Master SOP

12:30 Lunch break


13:30

Dr Tanja Peters

PV quality management and compliance
  • 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 creation and measurement
  • KPI basics: From mandatory to optional
  • Exercise: Quantitative and qualitative KPIs
  • Tracking and dashboard reporting

15:00 Coffee break


15:30

Dr Tanja Peters

Audits and inspections
  • Legal framework and regulatory authorities
  • Regulatory expectations towards the pharmaceutical company
  • Corrective and Preventive Action (CAPA)

16:00

Both speakers

Workshop: Inspection readiness
  • You have received an invitation to a local inspection - how do you prepare?

16:45

Both speakers

Discussion and Q&A session

17:00 End of the seminar


More information

Important for your participation

Please note: This is an interactive virtual course with live group work and collaborative exercises. A stable internet connection and an active webcam are mandatory for participation. Being visible and reliably connected is essential to meet the course objectives. Participants without proper technical setup may not be able to complete the course successfully. Thank you for ensuring you are fully equipped to engage throughout the two days.

With learning assessment and certificate

After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space as proof of your learning progress. Upon successfully passing the test, you will receive a certificate as "Qualified Person for Pharmacovigilance" in addition to your certificate of attendance.

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.

Pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

This distinguishes our events

of 5 stars of all ratings from 2024

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Necessary PV documents, contents and a medical writing checklist as a short overview.

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In-house seminars

Our programmes are also available for in-house training. Just contact us!

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In-house seminars
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality

Testimonials

The training was comprehensive and provided lots of hands on advice. The instructors were very knowledgeable and had a lot of practical experience. I really liked it and would definitely recommend it to new and even seasoned QPPVs.

You gave us a lot of input andi nformation about how to improve our PV system. Experinced speakers.

In depth training, excellent information provided, prepares for a good theoretical knowledge.

Good overview, practical examples, working sessions, individual questions were answered.

Lots of practical items and clear message were provided, speakers were engaged and have a lot of know how.

It gave an overall broad overview of task and responsibilities of QPPV/deputy QPPV. Good examples - practical advise - workshop!