Introduzione
Generative & Agentic AI in Life Sciences:
From AI Use to Responsible AI Governance
Generative AI is rapidly becoming part of everyday work across Life Sciences. From literature reviews andmedical writing to content development and decision support, its potential to improve efficiency and support increasingly complex activities is significant.
But using AI effectively is not just about knowing the right tools or prompts. In a regulated environment, professionals also need to understand how these systems work, where their limitations lie and what risks may arise from inaccurate outputs, bias, lack of traceability or inappropriate levels of automation.
This becomes even more important as AI evolves from generative tools to agentic systems capable of performing increasingly autonomous tasks.
Technology may change, but accountability remains human.
How can you assess whether an AI-generated output is reliable? When should human oversight intervene? How do the AI Act, GDPR and GxP requirements affect the use of AI? And how can AI solutions be introduced without losing control over compliance, scientific quality and accountability?
This course goes beyond basic AI use to provide professionals with the knowledge and practical tools to evaluate, design and govern Generative and Agentic AI responsibly in Life Sciences.
Through real-world use cases and hands-on exercises, participants will learn how to recognise risks, apply governance principles and make informed decisions about when, how and under which conditions AI can be used safely and effectively.
Programme
Advanced Generative AI & the AI Act
Move from using AI to understanding and controlling it
- How generative AI works: LLMs and multimodal models
- Advanced prompt engineering and prompt chaining
- Fine-tuning vs RAG: understanding the different approaches
- Hallucinations, bias and reliability: recognising the limits of AI-generated outputs
- AI system classification under the AI Act
- Generative AI as General Purpose AI (GPAI)
- Hands-on: build complex prompts for Medical Affairs and perform an AI risk analysis
Agentic AI & AI Agents
Understand what changes when AI becomes more autonomous
- From traditional chatbots to AI Agents
- How AI Agents work: memory, goals, tools and human-in-the-loop supervision
- Single-agent vs multi-agent systems
- Specific risks and governance challenges of Agentic AI
- The impact of the AI Act on agentic systems
- Life Sciences use cases: literature review, supervised medical writing and field medical support
- Hands-on: design the concept of a compliant AI Agent
AI Governance, Compliance & Risk Management
Turn responsible AI principles into practice
- Building an effective AI governance framework
- Applying a risk-based approach under the AI Act
- Documentation, traceability, auditability and explainability
- Vendor AI vs internally developed AI: different responsibilities and risks
- Connecting AI Act, GDPR and GxP requirements
- Hands-on: create a mini AI policy and assess the compliance of an AI system
Life Sciences professionals working in regulated environments who already use or are familiar with generative AI and want to develop a deeper, responsible understanding of AI systems such as:
- professionals in Medical Affairs, Medical Marketing of Pharma, and Biotech
- roles involved in decision-making, innovation, compliance, or governance of AI-enabled processes
- professionals who need to assess, supervise, or govern AI applications without being technical developers
Participant experience
Basic knowledge of generative AI and the AI Act (LSAcademy basic training or equivalent).
This course is designed as a highly interactive learning experience, combining expert-led sessions with real-world case discussions and hands-on exercise
Docente/i
Marco Anelli
Marco has a medical degree from the University of Milan, specializations in Medical Statistics and Clinical Pharmacology from the University of Pavia and an international master’s degree in health economics and pharmacoeconomics from the University of Pompeu Fabra in Barcelona, plus formal training in Data Science and Artificial Intelligence. In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment. Marco has been a free-lance consultant in Medical Affairs and Pharmacovigilance/ Drug Safety since 2022. Before that, he has been “Head of Pharmacovigilance and Medical Affairs Advisory Services” at ProductLife Group (PLG). As “Deputy Chief Scientific Officer”, always at PLG, Marco has also coordinated all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning. Previously, Marco was R&D Director at Keypharma, an Italy-based consultancy company (later acquired by PLG), where was responsible for the oversight of all clinical and preclinical aspects of projects run internally and on behalf of clients. Drawing on a career in the pharmaceutical industry that spans more than 30 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities. Marco has participated in and supervised all stages of drug development – from formulation to Phase I-IV and pharmacovigilance. In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries. Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand.
Giovanna Gelmi
Giovanna Gelmi is a Clinical Data Manager since 2019 and a Medical Writer since 2021. As a freelancer, she specializes in creating online courses, conference materials, and presentations, overseeing not only the written content based on client requests but also the graphic design, audio, and video production.
She holds a Master’s degree in Food Science and Technology, as well as in Agricultural Science, both from the University of Milan, along with a Master’s in Project Management. After completing her Master’s, she spent a year conducting research at the Escuela Politécnica Nacional de Quito in Ecuador, where she stayed two more years working on development projects.
Upon returning to Italy, she taught Food Science, and Biology before relocating to Germany with her husband. There, she studied Clinical Data Management at the Medicine Institute of Cologne and worked as a Clinical Data Manager at Uniklinikum Köln.
Giovanna founded Med with Groove, a company dedicated to medical writing, and has since focused on bridging the gap between medical affairs and advanced AI technologies, ensuring compliance and ethical practices in a rapidly evolving industry landscape. Her teaching style is particularly distinctive, marked by her special touch and ability to make lessons practical, engaging, and lively, with a strong emphasis on real-world applications.
More recently, she has expanded her expertise into the fields of AI Act and AI Governance, focusing on their application within Medical Affairs.
Online Training – 2 modules
MODULE 1 | 22 June 2027 from 2:00 pm to 6:00 pm CEST
MODULE 2 | 24 June 2027 from 2:00 pm to 6:00 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 995,00* (until 01 June 2027)
Ordinary: € 1.195,00*
Freelance – Individual–Academy – Public Administration: € 695,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
