Discover the course
WEBINAR: Attributability in Pharmacovigilance, Still a Hot Topic
How to navigate the different algorithms and approaches used to evaluate the causality of an adverse event/reaction
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.
- Causality: a “moving target”
- Brief review of the recent published evidence
- The position of GVPs
- The different algorithms (WHO, Naranjo, etc.): pros and cons
- A step by step example
- A possible integrated approach
- The new frontier: can Artificial Intelligence help?
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 coordinates 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 coordination 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 coordinated 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.
Medical reviewers, Pharmacovigilance Managers and Officers.
Webinar online: 2 April 2020 at 11 am
After the registration you will receive all details about the connection
Wednesday, April 1, 2020
At the end of the training, you will be able to
Have a working/critical knowledge of the causality attribution process and of the different approaches used, in order to be able to evaluate and set up (modify, if needed) an “ad hoc” process