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
  • 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?

    Medical reviewers, Pharmacovigilance Managers and Officers.

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

    Docente/i
    Marco Anelli
    Info

    Marco Anelli

    Senior Medical Advisor - 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 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.

    Online training 

    March, 22nd 2022         09:00 am – 01:00 pm CET

    After the registration, 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: € 395,00* (until 22/02/2022)

    Ordinary: € 515,00*

    Freelance – Academy – Public Administration**: € 295,00*


    *
     for Italian companies: +22% VAT

    **Early Bird discount not applicable to Freelance – 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.

    Acquista
    Early bird
    Acquistabile fino al 22/02/2022
    395,00
    Ordinaria
    Acquistabile fino al 21/03/2022
    515,00
    Freelance - Accademia - Pubblica Amministrazione
    Acquistabile fino al 21/03/2022
    245,00
    Svuota

    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>