2024-11-01 2024-11-01 , 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
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

Dr. Christian M. Moers

Sträter Lawyers, Bonn, GERMANY

Lawyer; His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows: - European and German medicinal product law - Marketing authorisation law & regulatory affairs - Pharmacovigilance - Wholesale trade with medicinal products, distribution of medicinal products - Manufacture of medicinal products
More information please click here.

Reinhold Schilling

Wörwag Pharma GmbH & Co. KG, Böblingen, GERMANY

Head of Global Pharmacovigilance, EU-QPPV

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

Downloads
List of Abbreviations Pharmacovigilance PROSPEKT
List of Abbreviations Pharmacovigilance PROSPEKT
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

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
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

FORUM Institut

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


Knowledge Test

Learning Snack

More information

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.

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We guarantee the highest quality

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

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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

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