Introduzione

EU regulations and Good Pharmacovigilance Practices (GVPs) require marketing authorisation holders to continuously monitor the benefits and risks of their medicines.
The benefit-risk assessment process, which requires pharmacovigilance expertise, challenges departments to meet critical integrated benefit-risk assessment requirements. Stakeholders may have different perspectives, including regulators, marketing authorisation holders, patients or prescribers.

This course aims to provide knowledge and understanding of the concepts and principles of benefit-risk assessment and to promote critical analysis of data for risk assessment.

It covers both qualitative and basic quantitative methods for benefit-risk assessment, with an emphasis on practical applications in decision making.
Special attention will be given to understanding the motivations and backgrounds of different stakeholders, as well as actions to minimise risks associated with medicines.

During the 2-module training,  the following topics will be covered:

  • Introduction
  • Decision context
  • Outcome selection and prioritization
  • Setting up literature searches
  • Data Extraction
  • Cohort Studies & Risk Ratio
  • Odds – Odds Ratio
  • Case Control
  • Quality
  • Benefit Evaluation
  • Risk Evaluation
  • Weighting Outcomes
  • Benefit-Risk
  • NNT/NNH
  • BRAT Framework
  • BRAT workshop
  • Result interpretation
  • Taking Action
  • Conclusions

This course is designed for personnel in the pharmaceutical industry involved in pharmacovigilance, clinical research and medical affairs

Participant’s experience: Suggested prerequisites include knowledge of relevant GVP guidelines (Module I, VI, V, and IX)

Interactive training

Docente/i
Francesco Tescione
Info

Francesco Tescione

European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C.
Francesco Tescione, European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C. dei F.lli Alitti, brings over a decade of experience in coordinating pharmacovigilance systems, quality, and risk management. With a background in Pharmacy and a Master's in Clinical Epidemiology and Guidelines, Francesco has served as Eu-QPPV for more than 10 years, contributing to international journals and training events on EVDAS and Signal Management

Online Training – 2 modules

MODULE 1 | 19 November 2024 from 9.00 am to 01.00 pm CET
MODULE 2 | 21 November 2024 from 9.00 am to 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: € 975,00* (until 29 October 2024)

Ordinary: € 1.185,00*

Freelance – Academy – Public Administration**: € 635,00*

* for Italian companies: +22% VAT

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

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

Registrati
Early bird
Acquistabile fino al 29/10/2024
975,00
Ordinary
Acquistabile fino al 18/11/2024
1.185,00
Freelance – Academy – Public Administration
Acquistabile fino al 18/11/2024
635,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Critically analyse the data sources associated with risks
Risultato atteso
Undertake a risk benefit analysis of a medicinal product
Risultato atteso
Outline strategies for optimising the benefit-risk balance
Risultato atteso
Understand current regulatory legislation and guidelines relevant to risk management

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