Advanced Class: The Global Network of Local and Regional QPPVs
Global Collaboration and Inspection Readiness
- Advanced seminar for pharmacovigilance professionals
- Strengthen global collaboration
- Includes interactive workshop sessions
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course materials, a certificate of participation, access to our Learning Space, technical support, including a test meeting, and an online test with an additional certificate when passed.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The fee includes high-quality course materials, a certificate of participation, access to our Learning Space, technical support, including a test meeting, and an online test with an additional certificate when passed.
This advanced online course strengthens collaboration between QPPV Offices and national PV teams. Centred on inspection readiness, it shows how global and local functions work together effectively.
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.
Per-Holger Sanden
Merck Healthcare KGaA
Inspection Management Lead
Per-Holger Sanden is an experienced and dedicated physician with extensive expertise in pharmaceutical quality assurance and process optimisation. Since…
Your speaker
Per-Holger Sanden
Merck Healthcare KGaA
Inspection Management Lead
Per-Holger Sanden is an experienced and dedicated physician with extensive expertise in pharmaceutical quality assurance and process optimisation. Since 2016, he has led Inspection Management at Merck Healthcare KGaA, coordinating over 160 inspection teams worldwide across GCP, GVP, and GLP. As a pragmatic troubleshooter, he combines in-depth knowledge with a passion for quality risk management and an interest in computer system validation.
What to Expect
- 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.
The seminar is designed for professionals in pharmacovigilance and is particularly relevant 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.
Objective of the Event
The responsibilities of both local and global Safety Officers require a sound understanding of drug and patient safety. However, it is not only one’s own area of work that must be understood. Effective collaboration within the network of QPPV, 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.
Programm
09:00-17:00 CE(S)T
You may dial in 30 min before the session 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
Reinhold Schilling
- Key responsibilities of the EU QPPV
- The role of national Safety Officers
- PV intelligence - communication with headquarters and local functions
09:45
Both speakers
- Europe: DE, UK, FR, CH, and others
- Global: Americas, Asia, Africa, Australia
- Typical challenges in cooperations
10:45 - 11:00
11:00
Per-Holger Sanden
- Corporate audits
- Auditor qualifications
- Remote audits
- Audit frameworks: GVP, ISO, and national legislation
11:30
Both speakers
- 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
12:00
Reinhold Schilling
- What regulators expect
- Language discrepancies
- Local vs global SOPs
- How can the HQ maintain oversight?
12:30 - 13:30
13:30
Both speakers
14:15
Per-Holger Sanden
- Effective communication across regions
- Local issues - solve or escalate?
- Building and maintaining a resilient global network
15:00 - 15:15
15:15
Per-Holger Sanden
- 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
16:00
Both speakers
- 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
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
The Network of QPPVs and national Safety Officers
The Network of QPPVs and national Safety Officers
Reinhold Schilling
- Key responsibilities of the EU QPPV
- The role of national Safety Officers
- PV intelligence - communication with headquarters and local functions
09:45
Local regulatory requirements
Local regulatory requirements
Both speakers
- Europe: DE, UK, FR, CH, and others
- Global: Americas, Asia, Africa, Australia
- Typical challenges in cooperations
Coffee break
11:00
Audits
Audits
Per-Holger Sanden
- Corporate audits
- Auditor qualifications
- Remote audits
- Audit frameworks: GVP, ISO, and national legislation
11:30
Global vs local PSMF
Global vs local PSMF
Both speakers
- 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
12:00
SOP management
SOP management
Reinhold Schilling
- What regulators expect
- Language discrepancies
- Local vs global SOPs
- How can the HQ maintain oversight?
Lunch break
Workshop: Your company expands into a theme park
14:15
What drives our global colleagues?
What drives our global colleagues?
Per-Holger Sanden
- Effective communication across regions
- Local issues - solve or escalate?
- Building and maintaining a resilient global network
Coffee break
15:15
Inspection readiness: Time to deliver
Inspection readiness: Time to deliver
Per-Holger Sanden
- 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
16:00
Risk and crisis management: Best practices
Risk and crisis management: Best practices
Both speakers
- 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 course
Downloads
Request the documents using our form.
Brochure: Qualification course Qualified Person for Pharmacovigilance (QPPV)
Abbreviation list Pharmacovigilance
Link list: Drug Safety Navigator
Technical setup
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.
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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