2023-01-30 2023-01-30 , online online, 1,190 € plus tax Dr. Sabine Jeck-Thole https://www.forum-institut.com/seminar/23022052-the-eu-qualified-person-for-pharmacovigilance-eu-qppv/referenten/23/23_02/23022052-course-eu-qppv_jeck-thole-sabine.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 on practic
  • Company-wide network and integration of an EU-QPPV
  • Liability and legal protection
Aims and objectives
The Qualified Person for Pharmacovigilance (QPPV) is a central role with a high level of responsibility, diverse tasks and duties in any pharmaceutical company.

This course provides important and practic knowledge about the tasks of a QPPV as well as the legal basis for their activities.

It will also examine the major issue of liability in detail and discuss the consequences of Brexit for an EU-QPPV.
Who should attend

This online course is intended for specialists and executives in the pharmaceutical industry, in particular those in pharmacovigilance, medical science, approval, clinical research and quality assurance and specifically for QPPVs.

Course EU QPPV

The EU Qualified Person for Pharmacovigilance (EU-QPPV)

Refresh your knowledge of the tasks and responsibilities of an EU-QPPV

Benefits
  • Interactive online format
  • Practical, first-hand information
  • Meet the experts!
  • Excellent networking opportunities
  • We are following the IMI quality criteria

Webcode 23022052

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

06/02/2023

06/02/2023

Period

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

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

online

online

Fee
Your contact

Dr. Henriette Wolf-Klein
Conference Manager

+49 6221 500-680
h.wolf-klein@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 on practic
  • Company-wide network and integration of an EU-QPPV
  • Liability and legal protection
Aims and objectives

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

This course provides important and practic knowledge about the tasks of a QPPV as well as the legal basis for their activities.

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

Who should attend

This online course is intended for specialists and executives in the pharmaceutical industry, in particular those in pharmacovigilance, medical science, approval, clinical research and quality assurance and specifically for QPPVs.

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

Dr Sabine Jeck-Thole, 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

Dr Sabine Jeck-Thole, Reinhold Schilling

Workshop based on practical case studies (e.g. PSMF, contracts, process descriptions including SOPs, audits and inspections

14:00 Coffee Break


14:15

Dr Sabine Jeck-Thole

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

15:30

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

Do you work in pharmacovigilance? Are you interested in courses conducted in English?

Then one of the following online courses could be just right for you. 3Find out more about 'The Pharmacovigilance System Master File (PSMF) in a Global Environment', a one-day course to be also held in February 2022, by searching for webcode 23022051 on our website.

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