Pharmacovigilance Auditing
Planning and conducting GVP Audits
- Compact training for new PV auditors
- Professional speakers from Big Pharma and consulting
- Interactive format with workshops and test
- Officially certified to the ISO 9001 and ISO 21001 standards
Online-Seminar
Ab
1.790,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.790,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
Period:
Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min before the course starts
Buchungsdetails
Online-Seminar
Ab
1.790,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.790,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test with an additional certificate upon passing.
Period:
Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min before the course starts
This compact, interactive 1.5-day online course equips you to independently plan and conduct pharmacovigilance audits in line with Good Pharmacovigilance Practices (GVP).
Your speakers
Dr. Ilona Schonn
elbPV Dr. Ilona Schonn
Owner and Principal Pharmacovigilance Consultant;
After completing her PhD in Clinical Pharmacy, Ilona began her career in the pharmaceutical industry in 2006. She gained…
Your speaker
Dr. Ilona Schonn
elbPV Dr. Ilona Schonn
Owner and Principal Pharmacovigilance Consultant;
After completing her PhD in Clinical Pharmacy, Ilona began her career in the pharmaceutical industry in 2006. She gained extensive experience in various roles, including as a Medical Manager, (Senior) Pharmacovigilance Manager, and finally as Group Leader PV Quality and Partner Management. In 2017, she founded her own consultancy, elbPV Dr Ilona Schonn, and has been working independently ever since. Today, she leads a team of professionals and supports clients in the areas of pharmacovigilance, and medical writing.
Ivana Vukic, MPharm
Senior Pharmacovigilance & Quality Expert
Senior Pharmacovigilance & Quality Expert;
Ivana is a Senior Pharmacovigilance and Quality Expert based in Munich and currently Quality Strategy Lead at Merck.…
Your speaker
Ivana Vukic, MPharm
Senior Pharmacovigilance & Quality Expert
Senior Pharmacovigilance & Quality Expert;
Ivana is a Senior Pharmacovigilance and Quality Expert based in Munich and currently Quality Strategy Lead at Merck. A pharmacist by training, she has extensive experience in PV, quality management and compliance since 2013, including roles as Deputy QPPV, Compliance QMC Manager and PV consultant. Her focus lies on risk-based auditing, quality assurance, process improvement and fostering transparent collaboration with internal teams and external partners.
What to Expect
- Qualifications and responsibilities according to GVP Module IV
- Conducting effective interviews
- Auditing of PV documents, contracts, and SDEAs
- Expectations of auditors and inspectors
- Risk-based audit strategy: Planning, scheduling, and execution
Who Should Attend
This course will be conducted in English.
This online course is aimed at professionals and managers in the pharmaceutical industry who aspire to, or have recently achieved, the role of GVP auditor and wish to plan and conduct pharmacovigilance audits independently and confidently in the future.
Work experience in pharmacovigilance of more than three years is recommended for this course.
Objective of the Event
In just 1.5 days, our compact, interactive training programme will fully prepare you to conduct sound Good Pharmacovigilance Practice (GVP) audits.
After covering the basics of the EU regulatory framework, the first day focuses on the key tasks of the auditor: Conducting interviews with PV responsibilities or managers and reviewing various PV documents.
Day 2 begins with a holistic view of all the areas that need to be assessed in a PV audit. Different strategies will be discussed depending on who is auditing whom and the risk-based approach to PV audits will be trained.
During the training, our qualified experts will answer many other additional questions such as:
- Where can I find supporting material such as checklists, templates, and questionnaires?
- What are the expectations of an inspector regarding the planning, execution, and documentation of an audit?
Your Benefit
Take advantage of this compact online training course and conduct future pharmacovigilance audits confidently, independently and successfully! The two workshops included will help you consolidate what you have learned and put it into practice.
After the seminar, you will be able to...
- accompany and conduct pharmacovigilance audits according to the latest regulations.
- conduct targeted and effective interviews.
- understand pharmacovigilance contracts and key pharmacovigilance documents in detail.
- develop risk-based audit strategies and audit plans.
Programme
Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min before
Day 1
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
Ivana Vukic, MPharm
- Responsibilities of the GVP auditor
- Components of the audit plan
- Types of PV audits
- Use of audit checklists, templates, and questionnaires
- Audit process
- Report and lean documentation
- Findings and CAPA
10:45 - 11:00
11:00
Dr Ilona Schonn
- Legal and GVP requirements
- Inspection review
11:45
Dr Ilona Schonn
- Requesting documents in advance
- PSMF - does a document really say it all?
- Reviewing SOPs and quality documents
- Reviewing RMPs
- Reviewing PASS, DSUR, PSUR, and PBER
- Considerations for document review
12:30 - 13:30
13:30
Dr Ilona Schonn
- Agreement types and differences
- Outsourcing of audits: integration of the external auditor
14:15
Ivana Vukic, MPharm
- Auditor attitude and approach
- Leading questions - effective questioning
- Objectivity and appreciation
15:00 - 15:15
15:15
Ivana Vukic, MPharm
- Interviewing the QPPV
- Interviewing PV roles and key interface functions
- In-process controls, KPIs and compliance
16:00
Both speakers
- Do's and don'ts
- Role play: The auditor and the auditee
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.
Start of course: Welcome and introduction
09:15
GVP audits - an overview
GVP audits - an overview
Ivana Vukic, MPharm
- Responsibilities of the GVP auditor
- Components of the audit plan
- Types of PV audits
- Use of audit checklists, templates, and questionnaires
- Audit process
- Report and lean documentation
- Findings and CAPA
Coffee break
11:00
Regulatory framework
Regulatory framework
Dr Ilona Schonn
- Legal and GVP requirements
- Inspection review
11:45
Efficient PV document review
Efficient PV document review
Dr Ilona Schonn
- Requesting documents in advance
- PSMF - does a document really say it all?
- Reviewing SOPs and quality documents
- Reviewing RMPs
- Reviewing PASS, DSUR, PSUR, and PBER
- Considerations for document review
Lunch break
13:30
Auditing contracts, SDEAs and service provider agreements
Auditing contracts, SDEAs and service provider agreements
Dr Ilona Schonn
- Agreement types and differences
- Outsourcing of audits: integration of the external auditor
14:15
The psychology of auditing
The psychology of auditing
Ivana Vukic, MPharm
- Auditor attitude and approach
- Leading questions - effective questioning
- Objectivity and appreciation
Coffee break
15:15
Conducting effective interviews
Conducting effective interviews
Ivana Vukic, MPharm
- Interviewing the QPPV
- Interviewing PV roles and key interface functions
- In-process controls, KPIs and compliance
16:00
Workshop: Conducting effective interviews
Workshop: Conducting effective interviews
Both speakers
- Do's and don'ts
- Role play: The auditor and the auditee
End of Day 1
Day 2
09:00
Both speakers
09:15
Dr Ilona Schonn
- Computerized systems and databases
- Monitoring and case processing
- Signal management
- Quality management
- Risk management
10:15
Both speakers
10:45 - 11:00
11:00
Ivana Vukic, MPharm
- Planning and scheduling
- Risks in the PV system
- Prioritisation methods
11:45
Both speakers
- Risk assessment and resource planning
- Audit strategy and annual audit plan
12:30
Both speakers
13:00
Start of Day 2: Wrap-up of the first day
09:15
Auditing the whole PV system and typical findings
Auditing the whole PV system and typical findings
Dr Ilona Schonn
- Computerized systems and databases
- Monitoring and case processing
- Signal management
- Quality management
- Risk management
Discussion: Who are you auditing?
Coffee break
11:00
Audit strategy and tactics: The risk-based approach
Audit strategy and tactics: The risk-based approach
Ivana Vukic, MPharm
- Planning and scheduling
- Risks in the PV system
- Prioritisation methods
11:45
Workshop: Developing a realistic audit strategy
Workshop: Developing a realistic audit strategy
Both speakers
- Risk assessment and resource planning
- Audit strategy and annual audit plan
Summary and discussion
End of course
PV Knowledge Check
Simply click on the answer you think is correct.
Downloads
Request the documents using our form.
Brochure
Abbreviation list - Pharmacovigilance
Further Informations
An interactive seminar with learning assessment and certificate
This event offers a combination of well-founded theoretical principles, practical workshops, and interactive discussions. To maximise your learning experience, we kindly ask you to keep your camera on whenever possible and actively participate.
After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space as proof of your learning progress. Upon successfully passing the test, you will receive a certificate as a "Certified Auditor for Good Pharmacovigilance Practices" in addition to your certificate of attendance.
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.
(October 2025)
The event materials were rated 5/5 stars.
(October 2025)
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Further Information
In-house seminars
Our programmes are also available for in-house training. Just 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