2024-12-03 2024-12-03 , online online, 1,290 € plus tax Alexander Maur https://forum-institut.com/seminar/25072050-artificial-intelligence-in-pharmacovigilance/referenten/25/25_07/25072050-course-artificial-intelligence-in-pharmacovigilance_maur-alexander.jpg Artificial Intelligence in Pharmacovigilance

Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.

Topics
  • Exploring artificial intelligence: ML, NLP, LLM, and more
  • Legal background and upcoming developments
  • AI in pharmacovigilance: Current capabilities and future potential
  • Trends, real-world examples, and projects
  • Workshop: Large Language Model in case processing


Who should attend
This course will be conducted in English.

This course is tailored for professionals in the pharmaceutical industry involved in the planning, implementation, or use of AI technologies in pharmacovigilance. Basic knowledge and/or practical experience in pharmacovigilance are required.
Aims and objectives
Artificial intelligence (AI) is widely regarded as the next key innovation with the potential to reshape the pharmaceutical landscape. The potential applications in pharmacovigilance are vast - they go beyond the capacities of deterministic (rule-based) systems and can even help with setting up and maintaining such systems with greater operational efficiency. The value proposition extends across the pharmacovigilance value chain - from streamlined and automated ICSR management to data monitoring, analysis and reporting. By examining past projects and ongoing developments, participants will gain a clear understanding of the current possibilities and future opportunities AI brings to the field.

Through expert-led discussions and practical examples, you'll learn how AI can enhance activities like ICSR management, safety screening, and signal detection. Workshops will give hands-on experience with AI applications, including LLM for case intake and processing. Join us to understand what is feasible now, what is on the horizon, and how AI can be integrated into your PV operations.
Your benefit

This online course about AI in pharmacovigilance will cover:

  • An understanding of AI technologies and their categories
  • Insight into current and expected regulatory guidelines
  • Exploration of practical AI applications in PV - past, present and future
  • Practical experience with the use of LLM in case processing
  • Experience with generative AI tools like ChatGPT and Microsoft Copilot to enhance daily workflows

Course Artificial Intelligence in Pharmacovigilance

Artificial Intelligence in Pharmacovigilance

Current State and Future Technologies in PV

Benefits
  • AI and its applications in pharmacovigilance
  • Includes pre-reading document on AI
  • Includes interactive workshop, real-world examples, and projects
  • Certified to ISO 9001 and ISO 21001 standards

Webcode 25072050

Book now

JETZT Buchen
Speakers

Alexander Maur

Kanzlei am Ärztehaus Frehse Mack Vogelsang, Cologne (Bayenthal), GERMANY

Lawyer and Partner
More information please click here.

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

Wei Wannhoff

Merck Healthcare KGaA, Darmstadt, GERMANY

Safety Data Analyst; After her studies in bioinformatics in Germany she was able to collect hands on experience in data management and SAE management in clinical research. She is an experienced professional with a strong focus on pharmacovigilance and drug safety management with 15 years of industry experience. Her career journey reflects a commitment to excellence, innovation, and compliance within the realm of drug safety and safety data retrieval. 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. She owns the important role as AI champion to lead the company-internal AI use cases in drug safety field.

Everything at a glance

Appointment

10/07/2025

10/07/2025

Period

09:00-17:00 CEST
You are welcome to join the session 30 minutes before it begins.

09:00-17:00 CEST
You are welcome to join the session 30 minutes before it begins.
Venue

online

online

Downloads
Fee

Event - 1,290 € plus tax
The fee includes high-quality course material for download, a certificate of participation, access to our Learning Space and technical support, including a test meeting.

Event - 1,290 € plus tax
The fee includes high-quality course material for download, a certificate of participation, access to our Learning Space and technical support, including a test meeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.

Topics

  • Exploring artificial intelligence: ML, NLP, LLM, and more
  • Legal background and upcoming developments
  • AI in pharmacovigilance: Current capabilities and future potential
  • Trends, real-world examples, and projects
  • Workshop: Large Language Model in case processing


Who should attend
This course will be conducted in English.

This course is tailored for professionals in the pharmaceutical industry involved in the planning, implementation, or use of AI technologies in pharmacovigilance. Basic knowledge and/or practical experience in pharmacovigilance are required.

Aims and objectives

Artificial intelligence (AI) is widely regarded as the next key innovation with the potential to reshape the pharmaceutical landscape. The potential applications in pharmacovigilance are vast - they go beyond the capacities of deterministic (rule-based) systems and can even help with setting up and maintaining such systems with greater operational efficiency. The value proposition extends across the pharmacovigilance value chain - from streamlined and automated ICSR management to data monitoring, analysis and reporting. By examining past projects and ongoing developments, participants will gain a clear understanding of the current possibilities and future opportunities AI brings to the field.

Through expert-led discussions and practical examples, you'll learn how AI can enhance activities like ICSR management, safety screening, and signal detection. Workshops will give hands-on experience with AI applications, including LLM for case intake and processing. Join us to understand what is feasible now, what is on the horizon, and how AI can be integrated into your PV operations.

Your benefit

This online course about AI in pharmacovigilance will cover:

  • An understanding of AI technologies and their categories
  • Insight into current and expected regulatory guidelines
  • Exploration of practical AI applications in PV - past, present and future
  • Practical experience with the use of LLM in case processing
  • Experience with generative AI tools like ChatGPT and Microsoft Copilot to enhance daily workflows

Detailed programme

09:00-17:00 CEST
You are welcome to join the session 30 minutes before it begins.

00:00

FORUM

Pre-reading: Fundamentals of artificial intelligence
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

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

09:00

FORUM

Welcome and introduction

09:15

Wei Wannhoff

What is artificial intelligence?
  • Automation, artificial intelligence and human intelligence
  • Machine learning (ML) and deep learning
  • Natural language processing (NLP) and large language model (LLM)
  • Generative AI

09:45

Alexander Maur

Legal background
  • The EU AI Act
  • The general data protection regulation (GDPR)
  • Local data protection regulations
  • Legal requirements for the validation of IT systems
  • Regulatory implications for pharmacovigilance activities
  • Implementation of AI: Responsibilities and organisational requirements

10:45 Coffee break


11:00

Wei Wannhoff

Introduction to AI in PV
  • Discussion: What PV activity do you would like to automate?
  • Scope in PV
  • Limitations and concerns
  • Currently feasible technologies and ongoing projects

11:30

Dr Ulrich Vogel

How AI can assist with deterministic PV tasks - automation
  • Rule-based automation vs machine learning
  • Decision principles for selecting a fit-for-purpose approach
  • Balance complexity, human involvement, and return on investment
  • Programmatic data analysis - AI as a companion coder
  • Other examples that worked, and examples that failed
  • Discussion

12:45 Lunch


13:45

Wei Wannhoff

Workshop: Large Language Model in case intake/processing
  • ICSR management: text extraction, structuring and output
  • Case intake/processing supported by LLM
  • Comparison of efficient with and without LLM support

14:45

All speakers

Discussion: What is feasible now?

15:15 Coffee break


15:30

Dr Ulrich Vogel

How AI can assist with non-deterministic PV task - judgments and associations
  • AI as a QC companion
  • Placing observations into clinical context
  • AI creativity - when and how it will fit the PV space
  • What are potential pitfalls, how can they be avoided

16:30

All speakers

Discussion and key takeaways

17:00 Course ends


Further information

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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In-house seminars

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List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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Abbreviations, Glossary
We guarantee the highest quality

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

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Testimonials

I was a great introduction into thetopic, explaining basic terminologyand modes of working of AI. Alsopractical examples were providedand existing commercializedsolutions. I liked the aspect of legalframework and ethics. The slidesare helpful to follow up certaintopics later.

Gives me an overview of thediff erent application of AI in PV.