Artificial Intelligence in Pharmacovigilance
Opportunities, Use Cases, and Implementation Essentials
- Opportunities, challenges, and limitations of AI in PV
- Includes pre-reading document
- Real-world examples and current experience
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ 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.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ 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 one-day online training explores practical AI applications in pharmacovigilance, including current use cases, hands-on applications of large language models, and the opportunities and limitations of AI-supported PV workflows.
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. Ulrich Vogel
Boehringer Ingelheim International GmbH
Head Strategic Data Analysis, Global Pharmacovigilance,
Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance;
Grounded in…
Your speaker
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH
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".
Wei Wannhoff
Merck Healthcare KGaA, Darmstadt
Associate Director Technology and Data Analytics;
After completing her bioinformatics studies in Germany, Wei gained hands-on experience in data management and SAE…
Your speaker
Wei Wannhoff
Merck Healthcare KGaA, Darmstadt
Associate Director Technology and Data Analytics;
After completing her bioinformatics studies in Germany, Wei gained hands-on experience in data management and SAE management in clinical research. She is an experienced professional with 15 years of industry experience and a strong focus on pharmacovigilance and drug safety management.
Throughout her career, she has combined excellence, innovation, and compliance within drug safety and safety data analytics. With a comprehensive understanding of regulatory requirements and a proven track record in data analysis, software tool development, and compliance management, Wei has demonstrated expertise in leading cross-functional teams and driving process improvements. As AI Champion at Merck, she leads internal AI use cases in the drug safety domain.
What to Expect
- AI use cases across pharmacovigilance processes
- Automation and AI support for structured PV tasks
- Large language models (LLM) and GPT prompting in PV practice
- AI for judgement-based tasks: opportunities and limitations
- Implementation, validation and inspection readiness
Who Should Attend
This seminar is designed for professionals who would like to understand how AI can be used in pharmacovigilance and how to assess meaningful use cases in practice.
Familiarity with core pharmacovigilance processes and terminology, as well as a basic understanding of AI concepts and terminology, for example from the whitepaper or an introductory course, is recommended.
Best suited for participants who
- are in an orientation or early exploration phase,
- would like to understand what is possible and where the limits are,
- want to assess prerequisites, opportunities and potential starting points,
- contribute to evaluation and planning, even without final decision-making authority.
Objective of the Event
Artificial intelligence is already being used in pharmacovigilance in a range of practical settings. This one-day online training looks at how AI can support PV processes today, from structured tasks and automation to use cases that require judgement, context and human oversight.
The focus is on practical application, real-world examples and current experience from companies. Participants will also explore what is needed to introduce AI into existing PV workflows, including validation, governance and inspection readiness.
Important: This seminar does not cover legal or regulatory fundamentals and is not a vendor presentation. The focus is on practical use, implementation and realistic discussion.
Your Benefit
This online course will provide...
- practical insights into AI use cases across PV processes.
- examples of where AI already supports daily PV work.
- hands-on experience with GPT prompting and LLM-supported workflows.
- perspectives on implementation, validation and inspection readiness.
- exchange with peers and industry experts.
You will leave the course with a clear view of the realistic potential of AI in pharmacovigilance and with the practical knowledge needed to identify relevant use cases and drive implementation within your organisation.
Programme
09:00-17:00 CE(S)T
You may dial in 30 min before the session starts
Two weeks before the course starts
To ensure all participants are on the same page and maximise time for real-world examples and projects, you will receive a pre-reading document that covers the fundamentals of artificial intelligence and clarifies key terms and concepts.
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
Wei Wannhoff
- AI basics in the PV context
- Quiz
- Generative AI: Hands-on exercise
- Where AI can support PV processes and where it cannot
10:00
Wei Wannhoff
- Build, buy or partner?
- Data quality and data ownership
- The impact on processes, technology and operating models
- From use case to implementation roadmap
10:45 - 11:00
11:00
Dr Ulrich Vogel
- Rule-based automation (RBA) and Large Language Models (LLMs) - best of both worlds
- Fit-for-purpose approaches
- Balancing complexity, human involvement, and return on investment (ROI)
11:45
Dr Ulrich Vogel
- AI for research, labelling and augmentation
- Contextualization of factual data
- Signal assessments
- Practical guardrails for human-in-the-loop verification
- Probabilistic uncertainty - where (and how) does it fit the PV space
12:45 - 13:45
13:45
Wei Wannhoff, Reinhold Schilling
- Where AI supports ICSR intake today
- Document triage, data extraction, and duplicate detection
- Automating MedDRA coding and exception handling
- Why recall matters more than accuracy
- Demonstration of feasible tools
14:30
Reinhold Schilling
- AI as a QC companion
- Case-level, cross-case and vendor-level quality checks
- Validating non-deterministic systems
- Model updates, drifts, and ongoing performance monitoring
- Audit trail and inspection-ready PSMF
15:15 - 15:30
15:30
Reinhold Schilling
- From keyword search to semantic screening
- Drafting case narratives with generative AI
- AI support for aggregate and regulatory documents
- Cross-document consistency and content review
- Human oversight and accountability
16:45
All speakers
17:00
Pre-reading: Fundamentals of artificial intelligence
Pre-reading: Fundamentals of artificial intelligence
Two weeks before the course starts
To ensure all participants are on the same page and maximise time for real-world examples and projects, you will receive a pre-reading document that covers the fundamentals of artificial intelligence and clarifies key terms and concepts.
08:45 - 09:00
Technical test
Technical test
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
Getting started with AI in pharmacovigilance
Getting started with AI in pharmacovigilance
Wei Wannhoff
- AI basics in the PV context
- Quiz
- Generative AI: Hands-on exercise
- Where AI can support PV processes and where it cannot
10:00
Organisational readiness for AI
Organisational readiness for AI
Wei Wannhoff
- Build, buy or partner?
- Data quality and data ownership
- The impact on processes, technology and operating models
- From use case to implementation roadmap
Coffee break
11:00
Apply AI to create, automate and maintain deterministic processes
Apply AI to create, automate and maintain deterministic processes
Dr Ulrich Vogel
- Rule-based automation (RBA) and Large Language Models (LLMs) - best of both worlds
- Fit-for-purpose approaches
- Balancing complexity, human involvement, and return on investment (ROI)
11:45
Apply AI in clinical context - judgment, creativity, augmentation
Apply AI in clinical context - judgment, creativity, augmentation
Dr Ulrich Vogel
- AI for research, labelling and augmentation
- Contextualization of factual data
- Signal assessments
- Practical guardrails for human-in-the-loop verification
- Probabilistic uncertainty - where (and how) does it fit the PV space
Lunch break
13:45
AI in ICSR intake and processing (incl demonstration of feasible tools)
AI in ICSR intake and processing (incl demonstration of feasible tools)
Wei Wannhoff, Reinhold Schilling
- Where AI supports ICSR intake today
- Document triage, data extraction, and duplicate detection
- Automating MedDRA coding and exception handling
- Why recall matters more than accuracy
- Demonstration of feasible tools
14:30
AI in quality assurance and oversight
AI in quality assurance and oversight
Reinhold Schilling
- AI as a QC companion
- Case-level, cross-case and vendor-level quality checks
- Validating non-deterministic systems
- Model updates, drifts, and ongoing performance monitoring
- Audit trail and inspection-ready PSMF
Coffee break
15:30
AI in literature monitoring, writing, and content review
AI in literature monitoring, writing, and content review
Reinhold Schilling
- From keyword search to semantic screening
- Drafting case narratives with generative AI
- AI support for aggregate and regulatory documents
- Cross-document consistency and content review
- Human oversight and accountability
Discussion and key takeaways
End of course
Downloads
Request the documents using our form.
Abbreviation list Pharmacovigilance
Further Informations
New to AI and German-speaking?
If you have little or no prior experience with artificial intelligence, we recommend starting with our introductory training KI verstehen - Fokus pharmazeutische Industrie first. It provides a structured overview of key concepts, terminology and typical application areas in the pharmaceutical environment, helping you build a solid foundation before moving into more practice-oriented discussions in pharmacovigilance.
Looking for broader, structured training? Have a look at our qualification programme
If you are interested in a more comprehensive qualification programme, this seminar can also be taken as part of our live online certificate course on AI in the pharmaceutical industry. The qualification programme comprises several interactive online seminar days in our Learning Space and covers the foundations of AI, practical evaluation of use cases, legally compliant use in pharmaceutical companies, and an individually selected area of specialisation such as Medical Affairs, Regulatory Affairs, Pharmacovigilance or Market Access.
Participants who attend all online trainings receive a digital final certificate as AI Manager in the Pharmaceutical Industry.
The full qualification programme is available in English: (AI Manager in the Pharmaceutical Industry (Webcode 60012205)) and in German: (KI-Manager in der pharmazeutischen Industrie (Webcode: 60012203)) on our website.
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Further Information
In-house seminars
Our programmes are also available for in-house training. Just contact us!
Newsletter on trends and findings
Stay up to date - we regularly inform you about new regulatory and professional developments.
We guarantee the highest quality
We are officially certified to ISO 9001 and ISO 21001 standard.
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