Pharmacovigilance Signal Management
Detection, evaluation and data processing in line with GVP Module IX
- Signal management: Concise and practice-oriented
- Complementary perspectives: MAH and regulatory authority
- Selected PRAC case studies
- Officially certified according to ISO 9001 and ISO 21001
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 with an additional certificate upon passing.
Booking details
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 with an additional certificate upon passing.
This interactive two-day seminar covers the regulatory fundamentals of signal management and their practical implementation through PRAC case studies, using EudraVigilance, programmable data analysis, and AI.
Your speakers
Larissa Kopp
Expert in Pharmacovigilance and Signal Management, WHO-Consultant;
Self-employed
With a background in biochemistry and molecular medicine, Larissa has specialised since 2020 in post-marketing safety…
Your speaker
Larissa Kopp
Expert in Pharmacovigilance and Signal Management, WHO-Consultant;
Self-employed
With a background in biochemistry and molecular medicine, Larissa has specialised since 2020 in post-marketing safety assessment of vaccines, monoclonal antibodies and allergen products.
She worked at the Paul-Ehrlich-Institut (PEI), Germany’s federal institute for vaccines and biomedicines, until April 2026, where she processed and analysed suspected adverse reaction cases, performed signal
management and assessed safety reports. Today, Larissa is self-employed and works, among other roles, as a freelance consultant for the World Health Organization (WHO). In addition, she supports the international development and strengthening of pharmacovigilance systems, for example in Lesotho.
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH, Ingelheim
Head Strategic Data Analysis, Global Pharmacovigilance,
Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance;
…
Your speaker
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH, Ingelheim
Head Strategic Data Analysis, Global Pharmacovigilance,
Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance;
Grounded in his training as a physician, Uli is focusing on transforming pharmacovigilance data into insights for medical risk identification and management. He acts as the global process owner for signal management and Head of the Safety Analytics and Data Science teams in pharmacovigilance. Uli is passionate about (visual) data communication and tailoring access to information in response to stakeholder demands. He is an active coder in R and D3.js and a member of CIOMS Working Group VIII "Practical Aspects of Signal Detection in Pharmacovigilance".
What to Expect
- GVP Module IX inclusive expected updates: content and practical implementation
- Implementing Regulation (EU) 2025/1466
- The signal management workflow based on selected PRAC case examples
- EudraVigilance and EVDAS
- Data analysis with R tidyverse
Who Should Attend
This course will be conducted in English.
This online seminar is designed for professionals in pharmaceutical companies who need to understand, implement and apply signal management in pharmacovigilance. The content is suitable both for experienced specialists and for those with initial professional experience.
Objective of the Event
Signal management is a core component of pharmacovigilance and is among the most frequent critical findings during inspections. In this seminar, you will learn how to fulfil regulatory requirements while keeping your processes efficient and lean.
On the first day, the focus is on the regulatory fundamentals and the signal management process. Step by step, the process is worked through and discussed based on practical PRAC examples.
The second day covers advanced topics such as communication with authorities, the use of EudraVigilance, data-driven analyses, digital automation and the role of artificial intelligence in signal management.
A special highlight: Benefit from two complementary viewpoints: The marketing authorisation holder (MAH) perspective from global pharmacovigilance practice and the regulatory perspective from a former assessor.
Your Benefit
After attending this online seminar, you will...
- know how to detect, prioritise, validate and assess signals.
- be able to apply efficient methods for data monitoring.
- understand the impact of signals on RMPs, safety reports and regulatory actions.
- understand statistical programming with R tidyverse and have suitable templates available.
- be well prepared for your next inspection.
Programme
09:00-17:00 CE(S)T each day
You may dial in 30 min before the session starts
Day 1
08:45 - 09:00
You are welcome to log in earlier to test your audio and video equipment before the event begins.
09:00
FORUM Institut
09:15
Larissa Kopp
- Definitions
- GVP Module IX
10:15
Both speakers
10:45 - 11:00
11:00
Larissa Kopp
- Roles and responsibilities: marketing authorisation holder, national competent authority and EMA
- Decision-making within the EU regulatory network
- Reporting pathways and timelines
- Role and involvement of PRAC
- PRAC examples (process flow)
12:00
Dr. Ulrich Vogel
- Implementing Regulations (EU) 2025/1466 and (EU) 520/2012
- Organisation and practical implementation
- Interfaces
- Applying EU terminology in your organisation (validation, confirmation, analysis, assessment)
- Prioritisation and decision-making
- PRAC examples (process flow)
12:45 - 13:45
13:45
Dr. Ulrich Vogel
- Termination of the pilot project: MAH signal detection in EudraVigilance
- New requirements for EudraVigilance monitoring
- Expected changes to GVP Module IX (Q2/3 2026)
14:45
Dr. Ulrich Vogel
- GVP IX Addendum I
- 2x2 contingency table and disproportionality analysis
- Reporting rates and trend analyses
15:15 - 15:30
15:30
Dr. Ulrich Vogel
- Quantitative and qualitative presentations
- Traceable documentation: Facts, assessments, and decisions
- PRAC examples (methods)
16:00
Larissa Kopp
- Quantitative methods for vaccines (observed vs expected)
- Practical examples
- PRAC examples (methods)
17:00
08:45 - 09:00
Technical warm-up
Technical warm-up
You are welcome to log in earlier to test your audio and video equipment before the event begins.
Start of the course: Welcome and introduction
09:15
Introduction to signal management
Introduction to signal management
Larissa Kopp
- Definitions
- GVP Module IX
Workshop: Introduction to selected PRAC case studies
Coffee break
11:00
Roles, responsibilities and process flow - Regulatory perspective (former assessor)
Roles, responsibilities and process flow - Regulatory perspective (former assessor)
Larissa Kopp
- Roles and responsibilities: marketing authorisation holder, national competent authority and EMA
- Decision-making within the EU regulatory network
- Reporting pathways and timelines
- Role and involvement of PRAC
- PRAC examples (process flow)
12:00
Roles, responsibilities and process flow - MAH perspective
Roles, responsibilities and process flow - MAH perspective
Dr. Ulrich Vogel
- Implementing Regulations (EU) 2025/1466 and (EU) 520/2012
- Organisation and practical implementation
- Interfaces
- Applying EU terminology in your organisation (validation, confirmation, analysis, assessment)
- Prioritisation and decision-making
- PRAC examples (process flow)
Lunch break
13:45
Implementing Regulation (EU) 2025/1466 and expected updates to GVP Module IX
Implementing Regulation (EU) 2025/1466 and expected updates to GVP Module IX
Dr. Ulrich Vogel
- Termination of the pilot project: MAH signal detection in EudraVigilance
- New requirements for EudraVigilance monitoring
- Expected changes to GVP Module IX (Q2/3 2026)
14:45
Identifying, assessing, and presenting signals - part I
Identifying, assessing, and presenting signals - part I
Dr. Ulrich Vogel
- GVP IX Addendum I
- 2x2 contingency table and disproportionality analysis
- Reporting rates and trend analyses
Coffee break
15:30
Identifying, assessing, and presenting signals - part II
Identifying, assessing, and presenting signals - part II
Dr. Ulrich Vogel
- Quantitative and qualitative presentations
- Traceable documentation: Facts, assessments, and decisions
- PRAC examples (methods)
16:00
Identifying, assessing, and presenting signals - part III
Identifying, assessing, and presenting signals - part III
Larissa Kopp
- Quantitative methods for vaccines (observed vs expected)
- Practical examples
- PRAC examples (methods)
End of day 1
Day 2
09:00
Please log in a bit early so we can start at 9:00.
09:05
Dr. Ulrich Vogel
- External communication
- Changes to the Company Core Data Sheets (CCDS) and the marketing authorisation
- PRAC examples (regulatory actions)
10:00
Larissa Kopp
- Qualitative signal detection at case level
- Causality assessment approaches
- Methods for medicinal products
- Methods for vaccines
- How quantitative and qualitative signal detection complement each other
- PRAC examples (methods)
10:45 - 11:00
11:00
Dr. Ulrich Vogel
- Electronic Reaction Monitoring Report (eRMR)
- Creating eRMRs in EVDAS: Practical demonstration with examples
- Regulatory expectations for marketing authorisation holders
12:00
Larissa Kopp
- Regulatory expectations for marketing authorisation holders
- Best practices for signal presentation in regulatory documents
- Common discussion points
- How to avoid follow-up questions
13:00 - 14:00
14:00
Larissa Kopp
14:30
Dr. Ulrich Vogel
15:00
Dr. Ulrich Vogel
- Opportunities and limitations
- Current state
15:15 - 15:30
15:30
Dr. Ulrich Vogel
- Analysing eRMRs
- Combining eRMRs with own data
- Calculating reporting rates
- Visualising results
- Or Excel instead? When switching is worth it
16:45
Both speakers
17:00
09:00
Start of day 2
Start of day 2
Please log in a bit early so we can start at 9:00.
09:05
Decisions and safety actions
Decisions and safety actions
Dr. Ulrich Vogel
- External communication
- Changes to the Company Core Data Sheets (CCDS) and the marketing authorisation
- PRAC examples (regulatory actions)
10:00
Qualitative signal analysis: Causality assessment
Qualitative signal analysis: Causality assessment
Larissa Kopp
- Qualitative signal detection at case level
- Causality assessment approaches
- Methods for medicinal products
- Methods for vaccines
- How quantitative and qualitative signal detection complement each other
- PRAC examples (methods)
Coffee break
11:00
EudraVigilance and EVDAS
EudraVigilance and EVDAS
Dr. Ulrich Vogel
- Electronic Reaction Monitoring Report (eRMR)
- Creating eRMRs in EVDAS: Practical demonstration with examples
- Regulatory expectations for marketing authorisation holders
12:00
Analysing signals efficiently and presenting them clearly
Analysing signals efficiently and presenting them clearly
Larissa Kopp
- Regulatory expectations for marketing authorisation holders
- Best practices for signal presentation in regulatory documents
- Common discussion points
- How to avoid follow-up questions
Lunch break
Audits and inspections - Regulatory perspective (former assessor)
Audits and inspections - MAH perspective
15:00
Rule-based automation and artificial intelligence
Rule-based automation and artificial intelligence
Dr. Ulrich Vogel
- Opportunities and limitations
- Current state
Coffee break
15:30
Data analysis with R tidyverse
Data analysis with R tidyverse
Dr. Ulrich Vogel
- Analysing eRMRs
- Combining eRMRs with own data
- Calculating reporting rates
- Visualising results
- Or Excel instead? When switching is worth it
Summary and open questions
End of the course
Downloads
Request the documents using our form.
Brochure
Abbreviation list - Pharmacovigilance
Further Informations
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