Hands-On Lab on AI Tools and Compliance with AI Act for Medical Affairs Professionals

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 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.