2023-11-28 2023-11-28 , online online, 1,190 € zzgl. MwSt. Dr. Christian M. Moers https://www.forum-institut.de/seminar/24022052-the-eu-qualified-person-for-pharmacovigilance-eu-qppv/referenten/24/24_02/24022052-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
  • 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, and for current QPPVs who wish to refresh their knowledge.
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 course will familiarise you with the roles, responsibilities and liabilities of a QPPV in the EU and explain how to integrate pharmacovigilance in your company.

It will also focus on how a QPPV delegates tasks, and provide 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
  • Meet the experts!
  • We are following the IMI quality criteria

Webcode 24022052

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Referenten


Alles auf einen Blick

Termin

21/02/2024

21/02/2024

Zeitraum

09:00 - 17:00You may dial in 30 min....

09:00 - 17:00
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
  • 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, and for current QPPVs who wish to refresh their knowledge.

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 course will familiarise you with the roles, responsibilities and liabilities of a QPPV in the EU and explain how to integrate pharmacovigilance in your company.

It will also focus on how a QPPV delegates tasks, and provide useful tips on how to build a worldwide QPPV network.

Detailed programme

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

09:00

Introduction and technical warm-up

09:20

Dr Christian M. Moers

Legal basis for the EU-QPPV
  • EU law
  • QPPV vs. national responsible person for pharmacovigilance
  • Impact of Brexit

10:05 Coffee break


10:20

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

12:40 Lunch break


13:30

Reinhold Schilling

Workshop based on practical case studies
  • 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


More information

Pre-meeting and technology check

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Overall impression: 100% of the participants’ feedback was very good or good (February 2023)

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