Artificial Intelligence in Pharmacovigilance
Exploring Today, Shaping Tomorrow
- Opportunities, challenges, and limitations of AI in PV today
- Includes pre-reading document on AI
- Real-world examples and projects
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
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.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
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 regulatory foundations and 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
Alexander Maur
Kanzlei am Ärztehaus Partnerschaft mbB, Cologne (Bayenthal), GERMANY
Lawyer and Partner;
Alexander Maur has been a partner at the law firm since 2007 and advises the healthcare industry on issues…
Your speaker
Alexander Maur
Kanzlei am Ärztehaus Partnerschaft mbB, Cologne (Bayenthal), GERMANY
Lawyer and Partner;
Alexander Maur has been a partner at the law firm since 2007 and advises the healthcare industry on issues relating to pharmaceutical and medical device law and associated areas of law at the firm's Cologne-Bayenthal office.
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY
Head Strategic Data Analysis, Global Pharmacovigilance,
Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in…
Your speaker
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY
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, GERMANY
Associate Director Technology and Data Analytics;
After completing her bioinformatics studies in Germany, Wei gained hands-on experience in data management and…
Your speaker
Wei Wannhoff
Merck Healthcare KGaA, Darmstadt, GERMANY
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
- Introduction to AI and its applications in pharmacovigilance
- Legal and regulatory frameworks
- AI to support rule-based (deterministic) and non-deterministic PV tasks
- Workshops: GPT prompting and Large Language Models
- Opportunities, challenges, and limitations of AI in PV today
Who Should Attend
This course will be conducted in English.
This course is tailored for professionals in the pharmaceutical industry who are involved in, or interested in, the application of AI technologies in pharmacovigilance.
No advanced AI expertise is required. The course, including the pre-reading document, also covers fundamental concepts. An open mindset towards AI and a willingness to learn new ways of working are important.
Objective of the Event
Artificial intelligence (AI) is driving innovation across industries, offering new opportunities to enhance efficiency in pharmacovigilance (PV) beyond traditional rule-based (deterministic) systems.
Currently, AI use in PV is still emerging. While promising, many applications face regulatory and validation hurdles. This seminar provides a clear and realistic perspective on what is achievable today, offering insights into current projects from Big Pharma and highlighting both opportunities and limitations. Participants will gain a solid understanding of essential AI concepts, regulatory frameworks, and practical use cases.
Through interactive discussions and hands-on workshops, including LLM-assisted case processing and GPT prompting, participants will learn how to effectively feed AI models with data and interact with generative AI tools. The focus is on identifying meaningful use cases and applying AI to streamline daily workflows.
Your Benefit
This online course about AI in pharmacovigilance will cover:
- Real-world use cases of AI automation in PV tasks.
- An understanding of the EU AI Act, GDPR, and their implications for AI in PV.
- Practical perspectives on AI in PV, including past experiences, current practices, and future trends.
- Knowledge exchange with peers and industry experts.
- Hands-on workshops, including LLM-assisted case processing and GPT prompt engineering to optimise workflows.
You will gain a clear overview of what AI can and cannot do today, with realistic examples, regulatory context, and real-world case studies. The focus is on learning, exchanging ideas, and exploring meaningful use cases.
Important: This is not a vendor or service provider presentation, and no lists of AI solution providers will be shared. Instead, the seminar centres on building understanding, exploring trends, and discussing practical applications.
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
- Quiz
- Generative AI: hands-on exercise
- What PV activities to automate: where AI helps, where it does not
- Scope in PV
10:30 - 10:45
10:45
Alexander Maur
- EU AI Act
- General data protection regulation (GDPR) and local regulations
- Validation of computerized systems
- Implications for PV and GxP developments
- EU Digital Omnibus: Planned legal changes and PV relevance
11:45
All speakers
- Data Quality (to be ready for AI)
- Data ownership and data improvement cycles
- Operating model impact: process and technology change
- QC update and inspection experience
12:30 - 13:30
13:30
Wei Wannhoff
14:00
Dr Ulrich Vogel
- Rule-based automation vs machine learning: Competing approaches or a winning combination?
- Fit-for-purpose approach
- Balance complexity, human involvement, and return on investment
- Examples that worked, examples that failed
15:00
Wei Wannhoff
15:30 - 15:45
15:45
Dr Ulrich Vogel
- Placing observations into clinical context
- Gen AI in signal assessment
- AI as a QC companion
- AI creativity: When and how it will fit the PV space
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
Foundations and use cases
Foundations and use cases
Wei Wannhoff
- AI basics
- Quiz
- Generative AI: hands-on exercise
- What PV activities to automate: where AI helps, where it does not
- Scope in PV
Coffee break
10:45
Legal background
Legal background
Alexander Maur
- EU AI Act
- General data protection regulation (GDPR) and local regulations
- Validation of computerized systems
- Implications for PV and GxP developments
- EU Digital Omnibus: Planned legal changes and PV relevance
11:45
Organizational readiness and change management
Organizational readiness and change management
All speakers
- Data Quality (to be ready for AI)
- Data ownership and data improvement cycles
- Operating model impact: process and technology change
- QC update and inspection experience
Lunch break
GAMP AI Guide
14:00
How AI can assist with deterministic PV tasks - automation
How AI can assist with deterministic PV tasks - automation
Dr Ulrich Vogel
- Rule-based automation vs machine learning: Competing approaches or a winning combination?
- Fit-for-purpose approach
- Balance complexity, human involvement, and return on investment
- Examples that worked, examples that failed
Practical demonstration: Large Language Model in case intake/processing
Coffee break
15:45
How AI can assist with non-deterministic PV tasks - judgments and associations
How AI can assist with non-deterministic PV tasks - judgments and associations
Dr Ulrich Vogel
- Placing observations into clinical context
- Gen AI in signal assessment
- AI as a QC companion
- AI creativity: When and how it will fit the PV space
Discussion and key takeaways
End of course
Downloads
Request the documents using our form.
Brochure
Abbreviation list Pharmacovigilance
Qualifikationslehrgang: KI-Manager in der pharmazeutischen Industrie (Prospekt)
Further Informations
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.
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Further Information
In-house seminars
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We are now 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