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

Artificial Intelligence in Pharmacovigilance

Date

Format

Online-Seminar

Fee

From 1.290,00 € plus VAT
Services & Process

Request Offer Request Offer

Date

Format

Online-Seminar

Fee

From 1.290,00 € plus VAT
Services & Process

Request Offer Request Offer

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…

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…

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…

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

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

You are welcome to log in a little earlier to test your audio and video equipment before the event begins.

09:00

Welcome and introduction
FORUM Institut

09:15

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
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

Coffee break

11:00

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
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

Lunch break

13:45

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
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

Coffee break

15:30

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

16:45

Discussion and key takeaways
All speakers

17:00

End of course

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.

You are welcome to log in a little earlier to test your audio and video equipment before the event begins.

09:00

Welcome and introduction

Wei Wannhoff

AI basics in the PV context
Quiz
Generative AI: Hands-on exercise
Where AI can support PV processes and where it cannot

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

Coffee break

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)

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

Lunch break

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

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

Coffee break

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

Discussion and key takeaways

17:00

End of course

Downloads

Request the documents using our form.

Abbreviation list Pharmacovigilance

Download

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.

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

Customer Testimonials

What satisfied participants say

"It was a great introduction into the topic, explaining basic terminology and modes of working of AI. Also practical examples were provided and existing commercialized solutions. I liked the aspect of legal framework and ethics. The slides are helpful to follow up certain topics later."

"Learned basics of what AI is, what we have to think about when implementing such technology in PV processes, what potential use cases are (including some commercial providers), and where the limitations might be."

"Very informative, interesting and enlightening. Definitely worth attending especially if you're in the PV department."

Our Recommendations

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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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Newsletter on trends and findings

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We guarantee the highest quality

We are officially certified to ISO 9001 and ISO 21001 standard.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.