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Artificial Intelligence in Pharmacovigilance and New Technologies. Do We Really Need them?

An overview of what the new digital technologies can do to improve cost/effectiveness and quality of Pharmacovigilance activities


2020 TBD





Artificial Intelligence in Pharmacovigilance and New Technologies. Do We Really Need them?

This 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.

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

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

Building a simple case

  • Analysis
  • Implementation
  • Testing
  • Reporting

The “human factor”

  • How will employees react?
  • What are the implications for training and career paths?

Course Language

The course will be in English.

Marco Anelli
Marco Anelli Head of Medical Affairs and Pharmacovigilance Advisory Practice - 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, along with formal training in Data Science (Johns Hopkins University) and a Professional Certificate on Applied AI from IBM.

This one-and-a-half-day 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

Attendees’ experience

Knowledge of basic pharmacovigilance
Basic knowledge of computers and productivity packages (Office, etc.)

Presentation, including hands-on exercises, and debates.

The training course will take place in Budapest

Upon Arrival
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.

Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.

Limited number of participants to encourage networking and discussion.

Training Room

All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.

Teaching materials

All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.

Certificate of attendance

Early Bird: € 1.280,00* (until 27 May 2020)

Ordinary: € 1.490,00*

Freelance - Academy - Public Administration**: € 780,00*

for Italian companies: +22% VAT

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

The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

Register now

Course Price

1490.00 €

Early Bird

Wednesday, December 30, 2020

1280.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details


1,5 days

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Have a working knowledge of relevant information on Artificial Intelligence in Pharmacovigilance

  • Have a working knowledge of the new technologies that could affect Pharmacovigilance operations in the near and medium-term future

  • Select the appropriate tools and processes to implement a new technologies-based approach

  • Set up simple but specific strategies

  • Interact with the tools and service vendors/providers to set up more complex solutions

  • Manage and report the information

Participants' Feedbacks

Teacher was very clear  and outstanding  knowledge of the contents 

Teachers very expert and very good in comunication

The course gave me clear examples

Discussion of the topics covered by the course, not only from the Pharmacovigilance point of view, but considering the interactions with other functions / other company departments

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Artificial Intelligence in Pharmacovigilance and New Technologies. Do We Really Need them?

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Terms & Conditions

The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail:  telephone: +39 (0)35.515684

The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail:  telephone: +39 (0)35.515684

The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail:  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.