Masterclass: Local QPPV, EU QPPV, and Head of PV
The premier seminar for experienced pharmacovigilance professionals
- 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
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, a final test with corresponding certificate, access to the Learning Space as well as technical support including a test meeting.
Period:
09:00-17:00 CE(S)T
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, a final test with corresponding certificate, access to the Learning Space as well as technical support including a test meeting.
Period:
09:00-17:00 CE(S)T
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 practical insights - from experts, for experts.
Your speakers
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG
Head of Global Pharmacovigilance, EU-QPPV, and local QPPV;
Reinhold Schilling is a recognised expert in the field of pharmacovigilance, with over a decade of experience in…
Your speaker
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG
Head of Global Pharmacovigilance, EU-QPPV, and local QPPV;
Reinhold Schilling is a recognised expert in the field of pharmacovigilance, with over a decade of experience in drug safety and regulatory requirements. Holding dual master’s degrees in Chemistry and Drug Regulatory Affairs, he has been heading the global drug safety department of Wörwag Pharma GmbH & Co. KG as Head of Global Pharmacovigilance since 2021.
In addition to his work in industry, Reinhold Schilling is also active in academia, serving as a lecturer in pharmacovigilance at Reutlingen University and at the Goethe Business School. As an active member of the BPI Pharmacovigilance Working Group, he contributes his expertise to the further development of regulatory frameworks.
Dr. Kerstin Stephan
- requested -
Senior Expert Pharmacovigilance, Bonn
Dr Kerstin Stephan graduated from Heinrich-Heine University in Düsseldorf in 1993. After that, she worked in a public pharmacy. Currently, she is a…
Your speaker
Dr. Kerstin Stephan
- requested -
Senior Expert Pharmacovigilance, Bonn
Dr Kerstin Stephan graduated from Heinrich-Heine University in Düsseldorf in 1993. After that, she worked in a public pharmacy. Currently, she is a lecturer in drug regulatory affairs at the Friedrich-Wilhelm University in Bonn and is also employed in a public institution.
What to Expect
- PV SOPs: Which processes require them, and when are they 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.
Objective of the Event
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
Programme
09:00-17:00 CE(S)T
You may dial in 30 min before the course starts
08:45 - 09:00
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.
09:00
FORUM Institut
09:15
- The SOP management system: Key features, essentials, and workflow
- Maintaining SOPs and SOP systems
- Which SOPs are required by regulation, and how should they be structured?
- What do inspectors focus on?
- Assessing errors and weaknesses in a Master SOP
10:15 - 10:30
10:30
- Maintaining the PSMF
- Tips for keeping the PSMF up to date
- The critical moment: When the PSMF is requested
11:15
- 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
11:45
The topic will be announced during the seminar. Participants are welcome to submit their preferences in advance.
12:15 - 13:15
13:15
- News from the PhV Inspectors Working Group
- PRAC updates
- CMDh developments
- News from the BfArM Inspectorate
13:45
- Regulatory affairs: The status of your safety variations
- Originator adoption: 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
14:30
- 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
15:30 - 15:45
15:45
- 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
16:45
17:00
08:45 - 09:00
Technical warm-up
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
09:15
PV SOPs: When are they useful?
PV SOPs: When are they useful?
- The SOP management system: Key features, essentials, and workflow
- Maintaining SOPs and SOP systems
- Which SOPs are required by regulation, and how should they be structured?
- What do inspectors focus on?
- Assessing errors and weaknesses in a Master SOP
Coffee break
10:30
PSMF: One document for clarity
PSMF: One document for clarity
- Maintaining the PSMF
- Tips for keeping the PSMF up to date
- The critical moment: When the PSMF is requested
11:15
Handling complaints and product recalls
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
11:45
Workshop
Workshop
The topic will be announced during the seminar. Participants are welcome to submit their preferences in advance.
Lunch break
13:15
Latest updates from the EMA
Latest updates from the EMA
- News from the PhV Inspectors Working Group
- PRAC updates
- CMDh developments
- News from the BfArM Inspectorate
13:45
Stakeholder management
Stakeholder management
- Regulatory affairs: The status of your safety variations
- Originator adoption: 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
14:30
Deviations
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
15:45
Special topics for EU QPPVs and local contact persons
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
Downloads
Request the documents using our form.
Brochure
Abbreviation list - Pharmacovigilance
Brochure - Qualification course Qualified Person for Pharmacovigilance (QPPV)
Brochure - Head of Pharmacovigilance
Weitere Informationen
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.
This is what distinguishes this event
The overall impression of the event was rated 5/5 stars.
(September 2025)
The event materials were rated 4.7/5 stars.
(September 2025)
Customer Testimonials
What satisfied participants say
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de