The attribution of a causality relationship is an essential part of the medical review of pharmacovigilance cases and is the one that requires the most an integrated approach using clearly defined procedures and clinical experience.
The aim of the training is to help PV specialists, case reviewers and medical reviewers to “navigate” the different possible approaches to causality attribution in PV.
Freelance Consultant and Senior Medical Advisor at PLG (Product Life Group)
Marco Anelli has been appointed in January 2016 "Head of Pharmacovigilance and Medical Affairs Advisory Services" at PLG. As “Deputy Chief Scientific Officer” of PLG, Marco has 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 ProductLife Group company, 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 25 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. In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment. He 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.
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