About
Attributability and Causality in Pharmacovigilance: Making the Right Assessment in a Complex Regulatory Landscape
Determining causality remains one of the most challenging and critical activities in pharmacovigilance. Regulatory expectations, scientific evidence and clinical judgment must be integrated to ensure robust and defensible safety evaluations.
This course will provide participants with a practical framework to understand, compare and apply the main causality assessment methodologies used in pharmacovigilance today. Through real-life examples and hands-on exercises, attendees will learn how to make informed decisions, improve consistency in case assessment and confidently address regulatory and audit expectations.
Programme
- Why causality assessment remains a moving target
- What recent evidence tells us about causality assessment
- GVPs and Causality assessment
- The Global Introspection
- WHO, Naranjo and beyond: choosing the right algorithm
- A step-by-step example
- A possible integrated approach
- Artificial Intelligence and the future of causality assessment
Medical reviewers, Pharmacovigilance Managers and Officers.
Participant experience: Basic concepts of Pharmacovigilance/Drug Safety and GVPs.
The course combines expert-led lectures, real-world case discussions and interactive exercises to ensure immediate application of concepts in daily pharmacovigilance activities.
Lecturers
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.
Online Training – 1 module
25 March 2027 from 2:00 to 6:00 pm CEST
Some days before the online training 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: € 495,00* (until 04/03/2027)
Ordinary: € 625,00*
Freelance – Individual – Academy – Public Administration: € 395,00*
*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.
Register
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.