The GVP Refresher
Established Principles and New Developments in Good Pharmacovigilance Practices
- Comprehensive pharmacovigilance training
- All GVP modules in two days
- Effective learning through interactive workshops
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
From
2.090,00 €
plus VAT
Services & Process
Veranstaltung - 2.090,-€ 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 including a certificate upon passing.
Booking details
Online-Seminar
From
2.090,00 €
plus VAT
Services & Process
Veranstaltung - 2.090,-€ 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 including a certificate upon passing.
The Good Pharmacovigilance Practices (GVP) Modules published by the European Medicines Agency (EMA) are the key reference for pharmacovigilance practice in Europe. This two-day online course offers a comprehensive and practice-oriented refresher on established requirements, current updates, and recent developments across the GVP Modules.
Your speakers
Dr. Eva Bauer
DREHM Pharma GmbH
Head of Medical Writing and Medical Affairs;
After studying biomedicine and biotechnology, Eva Bauer initially spent several years in research. During her PhD studies, her passion for…
Your speaker
Dr. Eva Bauer
DREHM Pharma GmbH
Head of Medical Writing and Medical Affairs;
After studying biomedicine and biotechnology, Eva Bauer initially spent several years in research. During her PhD studies, her passion for writing deepened, which is why she started to work as a medical writer and medical affairs manager for the Austrian consultancy DREHM Pharma GmbH in 2016. She is now head of the associated department and has not only accompanied numerous vigilance writing projects in her past, but has also spent several months as case manager.
Anika Staack
ARC-Traicoa UG
Founder and PV Expert,
Consultant, EU-QPPV and local QPPV;
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining…
Your speaker
Anika Staack
ARC-Traicoa UG
Founder and PV Expert,
Consultant, EU-QPPV and local QPPV;
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regarding PV and also for PV inspections. Anika has been working in the pharmaceutical industry since 2003, holding positions of increasing responsibility. She has extensive experience in clinical research operations and holds a Master of Science degree in biology from Marburg University
Dr. Stefan Zohmann
DREHM Pharma GmbH
Joint Owner and CEO;
Stefan Zohmann joined the pharmacovigilance department of service provider DREHM Pharma in 2006 as a PSUR author and case manager. Since 2007 he has been working…
Your speaker
Dr. Stefan Zohmann
DREHM Pharma GmbH
Joint Owner and CEO;
Stefan Zohmann joined the pharmacovigilance department of service provider DREHM Pharma in 2006 as a PSUR author and case manager. Since 2007 he has been working as a QPPV for numerous national and international companies and has set up pharmacovigilance systems of all sizes. In recent years, his focus has increasingly shifted towards auditing, from marketing authorisation holders to distributors and licensors. Stefan Zohmann is now Co-CEO and co-owner of DREHM Pharma.
What to Expect
- GVP Modules I-XVI and Annexes
- Pharmacovigilance system master file (PSMF)
- Monitoring, documenting and evaluating adverse drug reactions
- Quality and risk management
- Audits and inspections
Who Should Attend
This course will be conducted in English.
This online course is designed for professionals in the pharmaceutical industry seeking reliable continuing professional development or a structured refresher in pharmacovigilance. It covers all GVP Modules, has a strong practical focus, and is primarily intended for PV Managers and experienced professionals working at the PV interface.
A basic understanding of pharmacovigilance and/or practical experience is required.
Objective of the Event
The Good Pharmacovigilance Practices Modules (GVP Modules), published and regularly updated by the European Medicines Agency (EMA), set out the standards and measures for the effective fulfilment of pharmacovigilance responsibilities and serve as a key reference for drug safety in Europe.
Refresh and expand your knowledge of GVP in this course and apply what you learn directly in practical workshops. The course covers a broad range of topics, from pharmacovigilance systems in general to key documents such as the PSMF and PSURs, as well as quality and risk management.
Each topic is discussed in direct relation to the relevant GVP Modules, ensuring that all modules, including annexes, are thoroughly covered.
Your Benefit
This online course will
- provide a comprehensive overview of all GVP modules.
- enable you to identify, collect and evaluate adverse events and adverse drug reactions.
- help you understand the structure and content of the PSMF, DSUR/PSUR and RMP.
- strengthen your ability to apply risk management methods in practice.
- provide practical experience through interactive workshops and help you prepare effectively for audits and inspections.
Programme
Both days: 09:00-17:00 CET
You can join 30 min before the course starts
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
09:15
Dr Stefan Zohmann
GVP Module I
- The pharmacovigilance system
- Authorities
- Legislation: EU regulations and directives, CIOMS, ICH
- GVP modules - structure and content
10:00
Anika Staack
GVP Module l
- EU QPPV
- Local QPPVs
- Other responsibilities
10:45 - 11:00
11:00
Dr Stefan Zohmann
GVP Module II
- General information
- Structure
- Specific content
11:45
Anika Staack
GVP Module VI
- Individual Case Safety Reports (ICSRs)
- Procedures
- Special cases
- Proper follow-up procedures
12:30 - 13:30
13:30
Dr Eva Bauer
GVP Module VII
- Legal basis and purpose
- Benefit-risk analysis
- Structure and content
14:15
Anika Staack
GVP Module VII
- Study protocol
- Study report
- Roles and responsibilities in the EU network
15:15 - 15:30
15:30
Dr Stefan Zohmann
GVP Module IX
- Introduction
- Structures and processes
- Operation in the EU network
16:00
Anika Staack
GVP Module X
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
The pharmacovigilance system - definitions, parties and legislation
The pharmacovigilance system - definitions, parties and legislation
Dr Stefan Zohmann
GVP Module I
- The pharmacovigilance system
- Authorities
- Legislation: EU regulations and directives, CIOMS, ICH
- GVP modules - structure and content
10:00
Roles and responsibilities in PV
Roles and responsibilities in PV
Anika Staack
GVP Module l
- EU QPPV
- Local QPPVs
- Other responsibilities
Coffee break
11:00
Pharmacovigilance system master file (PSMF)
Pharmacovigilance system master file (PSMF)
Dr Stefan Zohmann
GVP Module II
- General information
- Structure
- Specific content
11:45
Adverse drug reactions
Adverse drug reactions
Anika Staack
GVP Module VI
- Individual Case Safety Reports (ICSRs)
- Procedures
- Special cases
- Proper follow-up procedures
Lunch break
13:30
Periodic safety update report (PSUR)
Periodic safety update report (PSUR)
Dr Eva Bauer
GVP Module VII
- Legal basis and purpose
- Benefit-risk analysis
- Structure and content
14:15
Post-authorisation safety studies (PASS)
Post-authorisation safety studies (PASS)
Anika Staack
GVP Module VII
- Study protocol
- Study report
- Roles and responsibilities in the EU network
Coffee break
15:30
Signal management
Signal management
Dr Stefan Zohmann
GVP Module IX
- Introduction
- Structures and processes
- Operation in the EU network
16:00
Presentation and workshop: Additional monitoring
Presentation and workshop: Additional monitoring
Anika Staack
GVP Module X
End of Day 1
Day 2
09:00
Anika Staack, Dr Stefan Zohmann
09:15
Dr Stefan Zohmann
GVP Module I
- Overview
- Standard operating procedures (SOPs) and work instructions (WIs)
- Key performance indicators (KPIs)
- Corrective and preventive actions (CAPAs)
10:45 - 11:00
11:00
Anika Staack, Dr Stefan Zohmann
GVP Module I
11:45
Anika Staack, Dr Stefan Zohmann
GVP Module I
12:30 - 13:30
13:30
Dr Stefan Zohmann
GVP Modules III and IV
- Audits
- Inspections
- Requirements for pharmaceutical companies
- Typical findings
14:15
Dr Stefan Zohmann
GVP Modules III and IV
15:00 - 15:15
15:15
Anika Staack
GVP Modules V, XV and XVI, and annexes
- Risk management system
- Risk management plan (RMP)
- Risk minimisation measures (RMMs)
- Educational materials
- Safety communication (annex II - templates DHPC and CP DHPC)
16:45
Anika Staack, Dr Stefan Zohmann
17:00
Day 2 begins: Roundup of day 1
09:15
The quality system in PV
The quality system in PV
Dr Stefan Zohmann
GVP Module I
- Overview
- Standard operating procedures (SOPs) and work instructions (WIs)
- Key performance indicators (KPIs)
- Corrective and preventive actions (CAPAs)
Coffee break
11:00
Workshop: Suitable key performance indicators (KPIs)
Workshop: Suitable key performance indicators (KPIs)
Anika Staack, Dr Stefan Zohmann
GVP Module I
11:45
Workshop: Corrective and preventive actions (CAPAs)
Workshop: Corrective and preventive actions (CAPAs)
Anika Staack, Dr Stefan Zohmann
GVP Module I
Lunch break
13:30
Audits and inspections
Audits and inspections
Dr Stefan Zohmann
GVP Modules III and IV
- Audits
- Inspections
- Requirements for pharmaceutical companies
- Typical findings
14:15
Workshop: Inspection readiness
Workshop: Inspection readiness
Dr Stefan Zohmann
GVP Modules III and IV
Coffee break
15:15
Risk management
Risk management
Anika Staack
GVP Modules V, XV and XVI, and annexes
- Risk management system
- Risk management plan (RMP)
- Risk minimisation measures (RMMs)
- Educational materials
- Safety communication (annex II - templates DHPC and CP DHPC)
Summary, questions and discussion
End of course
Downloads
Request the documents using our form.
Abbreviation list 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.
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 5.0/5 stars.
(July 2025)
The event materials were rated 5.0/5 stars.
(July 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