2025-03-28 2025-03-28 , online online, 1,290 € zzgl. MwSt. Reinhold Schilling https://forum-institut.de/seminar/25092053-masterclass-local-qppv-eu-qppv-and-head-of-pv/referenten/25/25_09/25092053-course-master-class-local-qppvs,-eu-qppv-and-head-of-pv_schilling-reinhold.jpg Masterclass: Local QPPV, EU QPPV, and Head of PV

Due to high demand - now available in English Are you experienced in pharmacovigilance and looking for in-depth knowledge on managing a PV system and leading your team? Do you have specific questions about your role as responsible person? Then this online event is for you! Gain insights and expertise - from experts for experts.

Topics
  • PV-SOPs - For which processes are they necessary/useful?
  • PSMF - One document for clarity
  • Handling complaints and product recalls
  • Stakeholder management
  • Deviation management and CAPA


Who should attend
This course will be conducted in English.

This seminar is designed for national QPPVs, EU QPPVs, and their direct team members who have already gained fundamental knowledge and experience in managing a PV system. At least three years of leadership experience in pharmacovigilance is recommended.
Aims and objectives
The responsibilities of local QPPVs, EU QPPVs, and senior PV professionals require in-depth expertise, even in specialised areas.

Benefit from the extensive experience of our expert speakers and expand your knowledge of key PV topics. Discover best-practice approaches to everyday challenges and ensure you are well-prepared for your next inspection.

After attending this seminar, you will be able to perform your duties as a PV professional even more efficiently.

Please note: This seminar does not cover the legal foundations or general responsibilities of QPPVs and local/national QPPVs. These topics are addressed in other seminars offered by FORUM Institut.
Your benefit

  • The high-end seminar for experienced PV professionals
  • Hands-on, practical insights - ready for implementation
  • Expand your network - from PV experts for PV experts
  • Dedicated time for discussions and specific questions

Course Master Class: Local QPPVs, EU QPPV and Head of PV

Masterclass: Local QPPV, EU QPPV, and Head of PV

The premier seminar for experienced pharmacovigilance professionals

Benefits
  • Specialised knowledge for experienced PV professionals
  • A compact, one-day format
  • High-level insights from industry experts
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 25092053

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Alles auf einen Blick

Termin

25/09/2025

25/09/2025

Zeitraum

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

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

online

online

Downloads
Gebühr
Your contact

Nadja Wolff
Conference Manager

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

Details

Due to high demand - now available in English Are you experienced in pharmacovigilance and looking for in-depth knowledge on managing a PV system and leading your team? Do you have specific questions about your role as responsible person? Then this online event is for you! Gain insights and expertise - from experts for experts.

Topics

  • PV-SOPs - For which processes are they necessary/useful?
  • PSMF - One document for clarity
  • Handling complaints and product recalls
  • Stakeholder management
  • Deviation management and CAPA


Who should attend
This course will be conducted in English.

This seminar is designed for national QPPVs, EU QPPVs, and their direct team members who have already gained fundamental knowledge and experience in managing a PV system. At least three years of leadership experience in pharmacovigilance is recommended.

Aims and objectives

The responsibilities of local QPPVs, EU QPPVs, and senior PV professionals require in-depth expertise, even in specialised areas.

Benefit from the extensive experience of our expert speakers and expand your knowledge of key PV topics. Discover best-practice approaches to everyday challenges and ensure you are well-prepared for your next inspection.

After attending this seminar, you will be able to perform your duties as a PV professional even more efficiently.

Please note: This seminar does not cover the legal foundations or general responsibilities of QPPVs and local/national QPPVs. These topics are addressed in other seminars offered by FORUM Institut.

Your benefit

  • The high-end seminar for experienced PV professionals
  • Hands-on, practical insights - ready for implementation
  • Expand your network - from PV experts for PV experts
  • Dedicated time for discussions and specific questions

Detailed programme

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

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

FORUM Institut

Welcome and introduction

PV-SOPs: When are they useful?
  • The SOP management system: Key features, essentials, and workflow
  • Maintaining SOPs and SOP systems
  • Which SOPs are regulatory required and how should they be structured?
  • What do inspectors focus on?
  • Assessing errors and weaknesses in a master SOP

Coffee break


PSMF - One document for clarity
  • Maintaining the PSMF
  • Tips for keeping the PSMF up to date
  • The critical moment: When the PSMF is requested

Handling complaints and product recalls
  • Worst-case scenario: The recall process
  • Global vs local handling
  • Documentation and archiving requirements
  • Preparing for the worst: Mock recalls
  • The role of the national contact Person for PV
  • Pitfalls and potential conflicts with internal interfaces

Workshop
The topic will be announced during the seminar. Participants are welcome to submit their preferences in advance.

Lunch break


Latest updates from the EMA
  • News from the PhV Inspectors Working Group
  • PRAC updates
  • CMDh developments

Stakeholder management
  • Regulatory affairs: The status of your safety variations
  • Originator contact Person for PV: When the originator is withdrawn from the market
  • Qualified Person: Regulations on product release and labelling
  • Marketing, market research, and social media: Identifying adverse event reporting channels
  • Supply chain: The key player in recalls
  • Managing drug shortages: Can older labels still be released?
  • Workshop: Effective risk analysis

Deviations
  • The quality system in PV: Requirements, responsibilities, and CAPA
  • Solid root cause analysis with real-world examples
  • Planning and implementing CAPA
  • Interim reports: Avoiding or postponing re-inspections
  • Documentation and tracking systems

Coffee break


Special topics for EU QPPVs and local Contact Persons
  • Organising efficient PV training - Every employee must report AEs
  • Budget planning in PV - What needs to be included?
  • Typical problem areas, conflict points, and solutions
  • "Fight for Talent" - How to attract the right candidates
  • Crisis communication on social media - Handling negative feedback with confidence

Open Q&A and discussion round


End of the seminar


Further information

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.

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.

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e-Learning - Click and learn

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In-house seminars

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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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We guarantee the highest quality