Introduzione
From AI Adoption to AI Responsibility - Understanding, Governing and Trusting AI in Life Sciences
Generative AI is rapidly becoming part of everyday activities in Medical Affairs, Medical Marketing, and Life Sciences organizations. From literature analysis to content drafting and decision support, these systems promise speed, efficiency, and scale. However, using AI without understanding how it works introduces significant risks.
Generative AI does not reason, verify facts, or understand scientific truth. It produces probabilistic outputs that may appear accurate, well-structured, and authoritative, while still being incomplete, biased, or incorrect. In regulated environments, such limitations are not technical details - they are business, compliance, and reputational risks.
Without a clear understanding of how generative and agentic AI systems function:
- errors may go undetected,
- regulatory obligations may be unintentionally breached,
- accountability may become unclear,
- and human oversight may be incorrectly delegated to automated systems.
As AI becomes more autonomous and more deeply embedded in medical and commercial processes, the responsibility remains entirely human. Understanding AI is therefore not about becoming a developer, but about ensuring control, governance, and trust.
This course is designed to build that awareness - enabling professionals to move from simply using AI tools to making informed, responsible decisions about when, how, and under which constraints AI should be applied in Life Sciences.
Programme
Advanced Generative AI & the AI Act – Move from AI usage to conscious AI design
- Architecture of generative models (LLMs, multimodal models)
- Advanced prompt engineering and prompt chaining
- Conceptual fine-tuning vs RAG (Retrieval-Augmented Generation)
- Hallucinations, bias, and reliability
- AI system classification under the AI Act
- Generative AI as General Purpose AI (GPAI)
Hands-on
- Building complex prompts for Medical Affairs
- AI risk analysis according to the AI Act
Agentic AI & AI Agents – Understand and govern autonomous AI systems
- What agentic AI is
- AI Agents vs traditional chatbots
- Agent architecture:
- Memory
- Goals
- Tools
- Human-in-the-loop supervision
- Single-agent vs multi-agent systems
- Specific risks of AI Agents
- Impact of the AI Act on agentic systems
Life Sciences Use Cases
- Agents for literature review
- Agents for supervised medical writing
- Agents supporting field medical teams
Hands-on
- Conceptual design of a compliant AI Agent
Governance, Compliance & Risk Management – Govern complex AI systems in regulated environments
- AI governance frameworks
- Risk-based approach under the AI Act
- Required documentation
- Traceability, auditability, and explainability
- Vendor AI vs internally developed AI
- Relationship between the AI Act, GDPR, and GxP
Hands-on
- Creating a mini AI policy
- AI system compliance assessment
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 (LS Academy 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 | 23 June 2026 from 2:00 pm to 6:00 pm CEST
MODULE 2 | 25 June 2026 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 02 June 2026)
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.
Registrati
Metodi di pagamento accettati: Bonifico bancario, Carta di credito, PayPal.
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