Introduzione

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.

  • 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: can Artificial Intelligence help?

    Medical reviewers, Pharmacovigilance Managers and Officers.

    The training comprises lectures, case history-based practical hands-on exercises.

    Docente/i
    Marco Anelli
    Info

    Marco Anelli

    Medical Affairs and Pharmacovigilance consultant
    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

    20 March 2024 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: € 440,00* (until 28/02/2024)

    Ordinary: € 560,00*

    Freelance – Individual – Academy – Public Administration**: € 285,00*

    * for Italian companies: +22% VAT

    ** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

    The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

    Registrati
    Early bird
    Acquistabile fino al 28/02/2024
    440,00
    Ordinaria
    Acquistabile fino al 19/03/2024
    560,00
    Freelance - Privato - Accademia - Pubblica Amministrazione
    Acquistabile fino al 19/03/2024
    285,00
    Svuota

    Barbara Rossi
    Barbara Rossi
    Training & Quality Manager
    Versione Stampabile
    Cosa saprai fare dopo il corso
    Risultato atteso
    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.

    <p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

    Online interactive training on Zoom platform. 

    LS Academy will provide the access link to the virtual platform a few days before the training.

    <p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>