Introduzione
Determining causality is a critical aspect of the medical review in pharmacovigilance cases, demanding a comprehensive, integrated approach that blends well-defined procedures with clinical expertise. This training is designed to empower pharmacovigilance specialists, case reviewers, and medical reviewers to expertly "navigate" through the various methods of attributing causality in pharmacovigilance.
- Causality: a “moving target”
- Brief review of the recent published evidence
- GVPs and Causality assessment
- The Global Introspection
- The different algorithms (WHO, Naranjo, etc.): pros and cons
- A step-by-step example
- A possible integrated approach
- The new frontier: will Artificial Intelligence help?
Medical reviewers, Pharmacovigilance Managers and Officers.
Participant experience
Basic concepts of Pharmacovigilance/Drug Safety and GVPs.
The training comprises lectures, case history-based practical hands-on exercises.
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.
Online Training – 1 module
26 March 2025 from 09:00 am to 01:00 pm CET
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: € 480,00* (until 05/03/2025)
Ordinary: € 610,00*
Freelance – Individual – Academy – Public Administration: € 390,00*
* 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.
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.
