Scope of this online training is to enable participants to make informed decisions and plan/implement strategies on the use of artificial intelligence (AI) in pharmacovigilance to manage the available pharmacovigilance information.

The course covers:

  • digital technologies from the regulatory framework to strategies, operational methods, and supporting technologies;
  • how to exploit the wealth of up-to-date structured and unstructured pharmacovigilance related information available (from traditional and innovative sources);
  • how to comply with current and future regulations;
  • gives an overview of the available data in the pharmacovigilance domain and of how to turn it into useable information and valuable knowledge to improve effectiveness and quality.

The following topics will be covered:

  • The scenario
    • Current and possible future regulations
    • Recent and future developments
    • Volume vs. quality
    • Case reports vs. intelligence
    • Automated reporting
    • What are the differences?
      • Machine learning
      • Artificial intelligence
      • Data science
      • Automation
  • Why do we need to do that?
    • Examples from real life
  • Challenges and rewards
  • A possible approach: modular
  • A use case: social networks
  • A case analysis: pharmacovigilance and signal management
    • Entry-level solutions
    • Next-generation solutions
      • Automated searches
      • Filtering and summarizing information
  • Building a simple case
    • Analysis
    • Implementation
    • Testing
    • Reporting
  • Where to find more information
  • The “human factor”
    • How will employees react?
    • What are the implications for training and career paths?


This 3 module online training course is designed to benefit functional/technical professionals coming from pharmaceutical and biotech companies, clinical research organizations (CROs) and public health centres dealing with the pharmacovigilance, such as:

  • Qualified Person for Pharmacovigilance (QPPV)
  • Pharmacovigilance officers
  • Quality assurance
  • Pharmacovigilance auditor
  • Knowledge manager 
  • IT manager

Participant experience 

– Knowledge of basic pharmacovigilance

– Basic knowledge of computers and productivity packages (Office, etc.)

Presentation, including hands-on exercises, and debates.  

Marco Anelli

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 – 3 modules

Module 1| October 21th, 2020            9:30 am – 13:00 pm CEST
Module 2| October 28th, 2020            9:30 am – 13:00 pm CEST
Module 3| November 04th, 2020         9:30 am – 13:00 pm CEST

After the registration, you will receive all details about the connection.


This online training admits a maximum number of 10-12 attendees


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: € 1.080,00* (until 30 September 2020)

Ordinary: € 1.260,00*

Freelance – Academy – Public Administration**: € 663,00*

* for Italian companies: +22% VAT

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

The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance that will be sent after the training via e-mail


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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Have a working knowledge of relevant information on Artificial Intelligence in Pharmacovigilance
Risultato atteso
Have a working knowledge of the new technologies that could affect Pharmacovigilance operations in the near and medium-term future
Risultato atteso
Select the appropriate tools and processes to implement a new technologies-based approach
Risultato atteso
Set up simple but specific strategies
Risultato atteso
Interact with the tools and service vendors/providers to set up more complex solutions
Risultato atteso
Manage and report the information

<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>