2025-04-02 2025-04-02 , online online, 1,290 € zzgl. MwSt. Per-Holger Sanden https://forum-institut.de/seminar/25122053-advanced-class-the-global-network-of-local-and-regional-qppvs/referenten/25/25_12/25122053-advanced-class-the-global-network-of-local-and-regional-qppvs_sanden-per-holger.jpg Advanced class: The Global Network of Local and Regional QPPVs

Are you a QPPV, local Safety Officer, or part of a QPPV office within an international MAH? Looking for a targeted training course to improve your day-to-day activities and collaboration with other PV professionals? This seminar shows you how.

Topics
  • Responsibilities and collaboration between QPPVs and National Safety Officers
  • Overview: Country-specific regulatory requirements
  • SOP and PSMF management
  • Local and global inspections and audits
  • Best practices in risk and crisis management


Who should attend
This course will be conducted in English.
This seminar is designed for professionals in pharmacovigilance and is particularly suitable for EU-QPPVs and local Safety Officers. Team members working within QPPV offices of international marketing authorisation holders will also benefit from attending.
Please note: A basic understanding of the responsibilities of QPPVs and local Safety Officers is required. This knowledge can be acquired through our corresponding foundation-level courses.
Aims and objectives
The responsibilities of both local and global Safety Officers require a sound understanding of drug and patient safety. Effective collaboration within the network of QPPVs, national Safety Officers, headquarters and affiliates can be demanding and occasionally lead to tension or inefficiencies.
In this advanced training, you will learn how to optimise your global collaboration and manage your responsibilities more efficiently as a Safety Officer.
Our experienced speakers will share best practices in communication, risk management, SOP and PSMF handling. Using the example of "Inspection Readiness", and through a workshop element, you will also gain valuable project management skills.
Your benefit

After completing this online seminar:

  • You will understand differences in various national requirements.
  • You will be well-prepared for your next inspection.
  • You gained practical experience in CAPA management and root cause analysis.
  • You will collaborate more effectively with your headquarters/affiliates, EU-QPPV, and local Safety Officers.

Online course - Advanced class: The Global Network of Local and Regional QPPVs

Advanced class: The Global Network of Local and Regional QPPVs

Global Collaboration and Inspection Readiness

Benefits
  • Advanced seminar for pharmacovigilance professionals
  • Strengthen global collaboration
  • Includes interactive workshop sessions
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25122053

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11/12/2025

11/12/2025

Zeitraum

09:00-17:00 CE(S)T
You may dial in 30 min before the session starts

09:00-17:00 CE(S)T
You may dial in 30 min before the session starts
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Nadja Wolff
Conference Manager

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

Details

Are you a QPPV, local Safety Officer, or part of a QPPV office within an international MAH? Looking for a targeted training course to improve your day-to-day activities and collaboration with other PV professionals? This seminar shows you how.

Topics

  • Responsibilities and collaboration between QPPVs and National Safety Officers
  • Overview: Country-specific regulatory requirements
  • SOP and PSMF management
  • Local and global inspections and audits
  • Best practices in risk and crisis management


Who should attend
This course will be conducted in English.
This seminar is designed for professionals in pharmacovigilance and is particularly suitable for EU-QPPVs and local Safety Officers. Team members working within QPPV offices of international marketing authorisation holders will also benefit from attending.
Please note: A basic understanding of the responsibilities of QPPVs and local Safety Officers is required. This knowledge can be acquired through our corresponding foundation-level courses.

Aims and objectives

The responsibilities of both local and global Safety Officers require a sound understanding of drug and patient safety. Effective collaboration within the network of QPPVs, national Safety Officers, headquarters and affiliates can be demanding and occasionally lead to tension or inefficiencies.
In this advanced training, you will learn how to optimise your global collaboration and manage your responsibilities more efficiently as a Safety Officer.
Our experienced speakers will share best practices in communication, risk management, SOP and PSMF handling. Using the example of "Inspection Readiness", and through a workshop element, you will also gain valuable project management skills.

Your benefit

After completing this online seminar:

  • You will understand differences in various national requirements.
  • You will be well-prepared for your next inspection.
  • You gained practical experience in CAPA management and root cause analysis.
  • You will collaborate more effectively with your headquarters/affiliates, EU-QPPV, and local Safety Officers.

Detailed programme

09:00-17:00 CE(S)T
You may dial in 30 min before the session starts

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

Welcome and introduction


Reinhold Schilling

The Network of QPPVs and national Safety Officers
  • Key responsibilities of the EU QPPV
  • The role of national Safety Officers
  • PV intelligence - communication with headquarters and local functions

Per-Holger Sanden, Reinhold Schilling

Local regulatory requirements
  • Europe: DE, UK, FR, CH, and others
  • Global: Saudi Arabia, Peru, and more
  • Typical challenges in cooperation: Public holidays, corruption, and more

Coffee break


Per-Holger Sanden

Audits
  • Corporate audits
  • External auditors
  • Remote audits
  • Audit frameworks: GVP, ISO, and national legislation

Per-Holger Sanden, Reinhold Schilling

Global vs local PSMF
  • Why a "One World PSMF" is often not practical and alternative approaches
  • Local Patient Safety File
  • Relevant chapters
  • Improving readability: Annexes, sub-annexes and shared annexes
  • Quality assurance

Reinhold Schilling

SOP management
  • What regulators expect
  • Language discrepancies
  • Local vs global SOPs
  • How can the HQ maintain oversight?

Lunch break


Per-Holger Sanden, Reinhold Schilling

Workshop: Your company expands into a theme park

Per-Holger Sanden

What drives our global colleagues?
  • Effective communication across regions
  • Local issues - solve or escalate?
  • Building and maintaining a resilient global network

Coffee break


Per-Holger Sanden

Inspection readiness: Time to deliver
  • Local inspections
  • Typical local findings
  • Local inspection readiness
  • CAPA: Immediate action or correction?
  • Drafting an effective CAPA plan
  • Global/HQ inspections
  • Workshop: Root Cause Analysis

Per-Holger Sanden, Reinhold Schilling

Risk and crisis management - best practices
  • Using the RAID approach for inspection planning
  • Best behaviour during inspections and investigations
  • Communicating with authorities
  • Risk minimisation plan and measures
  • Workshop: Business Continuity Planning

Summary and Q&A Session

End of Seminar


What you should know

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.

Free 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.

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

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