Overview

This course provides practical orientation for senior pharmacovigilance (PV) and IT professionals on the next level of technology transformation in PV. The rapid advancements in artificial intelligence (AI) over recent years have significantly impacted the way pharmacovigilance operates or may operate. With technologies such as machine learning and large language models being integrated into daily workflows, a new skillset is urgently needed.

This live virtual training is designed to equip experienced PV professionals with the knowledge and confidence to make informed decisions about AI adoption. Participants will learn how to apply AI tools in a smart, compliant, and impactful way.

The program is led by pharmacovigilance and IT veterans with hands-on experience in deploying AI technologies across PV systems. A regulatory viewpoint will be featured in dedicated panel discussions, including representation from the UK’s MHRA, ensuring participants gain insight into evolving expectations and frameworks.

Participant Testimonials

It was simply fascinating to have so much going on in the AI PV world; I’m excited to gain more knowledge. – Shachi Patel – Associate, PV Operation, Global Case Management, Moderna, US

The course was an outstanding experience which exceeded my expectations. If you're looking to stay ahead in PV and understand the practical implications of AI technologies, I highly recommend this course. Huge thanks to the expert hosts who showcased their extensive PV, IT and regulatory expertise. Insights from the MHRA were particularly valuable, offering a pragmatic and collaborative regulatory perspective. – Sabita Mukherjee – COO, Essjay Solutions Ltd. UK

I think this was an excellent course. I have played around with ChatGPT at home outside the professional context and was impressed with its capabilities. This course was an eye-opener for me what AI can and will do in the future in PV. – Dr. Morten Pantke -

Featured topics

- PV journey from manual through RPA to AI
- AI fundamentals for PV
- Compliance and management perspective on implementing intelligent automation
- Today’s PV interfaces and systems
- Near future PV IT developments
- Developing regulatory environment for AI in PV

Who should attend?

This course is ideal for pharmacovigilance and IT professionals with at least 2 years of PV experience who seek a comprehensive and practical overview of the AI technologies transforming the pharmacovigilance industry. It is especially relevant for:
- PV team leaders and managers
- Quality and compliance professionals
- Business process owners
- Digital transformation and IT specialists
- Regulatory affairs professionals involved in PV oversight

Learning objectives

- Understand the fundamentals of key AI methodologies, including machine learning, natural language processing, classifications, large language models (LLMs), and other ML variants.
- Explain the benefits and limitations of leading AI tools already in use in PV, such as OpenAI ChatGPT, Google Gemini, Anthropic Claude, Microsoft Copilot, and others.
- Recognize and manage risks related to data privacy, data security, bias, and ethical concerns in AI applications.
- Discuss the organizational implications of AI, including governance, audit readiness, workforce enablement, and change management.
- Evaluate the AI capabilities of current PV IT platforms (e.g., Oracle Argus, IQVIA IVP, RxLogix, ArisGlobal LifeSphere).
- Envision the ideal intelligent PV IT system of the future and contribute ideas toward its development.
- Build a roadmap for successful AI implementation tailored to their organizational needs.
- Learn how to integrate digital workforce technologies in pharmacovigilance operations.

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Artificial Intelligence in Pharmacovigilance