2025-01-04 2025-01-04 , online online, 1,290 € zzgl. MwSt. Dr. Christian M. Moers https://www.forum-institut.de/seminar/25022052-the-eu-qualified-person-for-pharmacovigilance-eu-qppv/referenten/25/25_02/25022052-course-eu-qppv_moers-christian-m.jpg The EU Qualified Person for Pharmacovigilance (EU QPPV)

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.

Topics
  • Legal basis for the EU QPPV
  • Regulatory requirements for practice
  • Specific tasks, responsibilities and possible delegations
  • Networking and integrating an EU QPPV across the company
  • Liability and legal protection


Who should attend
This course will be conducted in English.

The course is specifically designed for new or future (EU) QPPVs and their deputies with a professional background in pharmacovigilance. Current QPPVs who wish to refresh their knowledge are also welcomed.
Aims and objectives
The Qualified Person for Pharmacovigilance (QPPV) is a central role in any pharmaceutical company, with a high level of responsibility and a variety of duties.

This course provides critical and practical information about the duties of a QPPV and the legal basis for their activities.

It will also examine the major issue of liability and discuss the consequences of Brexit for an EU QPPV.
Your benefit

This online course

  • familiarises you with the roles, responsibilities and liabilities of a QPPV in the EU.
  • explains how to integrate pharmacovigilance in your company.
  • enables you to delegate QPPV tasks.
  • provides useful tips on how to build a worldwide QPPV network.

Course EU QPPV

The EU Qualified Person for Pharmacovigilance (EU QPPV)

Starter and refresher of the duties and responsibilities of a QPPV

Benefits
  • Legal basis for the EU-QPPV
  • Practical, first-hand information
  • Professional speakers from Big Pharma and legal backgrounds
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 25022052

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11/02/2025

11/02/2025

Zeitraum

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

09:00 - 17:00 CET
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

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.

Topics

  • Legal basis for the EU QPPV
  • Regulatory requirements for practice
  • Specific tasks, responsibilities and possible delegations
  • Networking and integrating an EU QPPV across the company
  • Liability and legal protection


Who should attend
This course will be conducted in English.

The course is specifically designed for new or future (EU) QPPVs and their deputies with a professional background in pharmacovigilance. Current QPPVs who wish to refresh their knowledge are also welcomed.

Aims and objectives

The Qualified Person for Pharmacovigilance (QPPV) is a central role in any pharmaceutical company, with a high level of responsibility and a variety of duties.

This course provides critical and practical information about the duties of a QPPV and the legal basis for their activities.

It will also examine the major issue of liability and discuss the consequences of Brexit for an EU QPPV.

Your benefit

This online course

  • familiarises you with the roles, responsibilities and liabilities of a QPPV in the EU.
  • explains how to integrate pharmacovigilance in your company.
  • enables you to delegate QPPV tasks.
  • provides useful tips on how to build a worldwide QPPV network.

Detailed programme

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

08:45

Technical warm-up
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00

Welcome and introduction

09:15

Dr Christian M. Moers

Legal basis for the EU-QPPV
  • EU law
  • QPPV vs national responsible person for pharmacovigilance

10:15 Coffee break


10:30

Reinhold Schilling

Regulatory requirements in practice
  • Qualification, 24-hour availability
  • Job description and integration into the organization chart
  • Delegation possibilities, boundaries and organisational infrastructure
  • QPPV as part of the company's safety governance

11:30

Reinhold Schilling

Concrete tasks of an EU-QPPV
  • Your role within a global patient safety and PV department
  • Interfacing with other departments such as regulatory affairs, commercial, medical, legal and quality assurance
  • External activities: networking and shaping the PV landscape

12:45 Lunch break


13:30

Reinhold Schilling

Liability and legal protection
  • Inspection readiness - You have received an invitation to a local inspection
  • What to do

14:15

Reinhold Schilling

A company's QPPV network
  • EU-QPPV: Monitoring worldwide
  • The post-Brexit scenario
  • QPPVs in other regions (EAEU, Arab countries, etc.)
  • Collaboration, exchange and overall responsibilities

15:15 Coffee Break


15:30

Dr Christian M. Moers

Liability and legal protection
  • Liability risks
  • Liability in the case of delegation
  • How to limit liability

16:45 Discussions and/or Q&A session


17:00 End of course


Seminar Extras

Competence Check

Are you ready to challenge your pharmacovigilance knowledge? Our interactive quiz offers an engaging and enjoyable way to assess your expertise.
Simply click on the answers you think are correct!

More information

Tailored Training for Your Company: In-House Seminars

  • Online, on-site, and hybrid formats
  • Available in German and English
  • Customised programmes

    Would you like to cost-efficiently train multiple employees in your company on a pharmacovigilance topic? This seminar is an example of our proven in-house training programmes. Whether you need an existing seminar concept, a specialised topic, or a tailored training for your organisation, we are here to support you!

    I would be delighted to plan your in-house training with you. Please feel free to contact me by phone or email. I look forward to your enquiry!

    Nadja Wolff
    Conference Manager Pharma/Healthcare
    n.wolff@forum-institut.de
    Phone: +49 6221 500-696

  • 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.

    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.

    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.

    This distinguishes our events

    of 5 stars of all ratings from 2024

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    Testimonials

    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!

    Very good training worth our time and money.

    Very good training for Senior PV managers, QPPV office staff, QPPVs.