Introduzione

The EU regulations and GVPs require MAHs to continuously monitor the benefits and risks of their medicines, whether authorised or under clinical investigation. The Benefit-Risk assessment is a process which involves various activities requiring pharmacovigilance experience and expertise.

Complying with the requirements for a critical integrated benefit risk evaluation can be a challenging exercise for any pharmacovigilance department. Furthermore, the perspective of different stakeholders (regulator, marketing authorisation holder, patient, or prescriber) may vary.

The objective of this course is to provide knowledge and understanding of the concepts and principles of Benefit-Risk assessment and lead to the critical analysis of data sources for the evaluation of risks. The course will show both qualitative and basic quantitative methods for Benefit-Risk assessment, including their practical application in decision making. Specific attention is given to the motivations and background of the different stakeholders, as well as the actions for minimising risks with medicines.

During the 3-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

Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, regulatory affairs.

Participant’s experience

Knowledge of the relevant GVP guidelines (Module I, VI, V and IX) and at least 2 years’ experience in pharmacovigilance are suggested.

Interactive training

Docente/i

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

Durata e Informazioni utili
Quote Iscrizione

Online Training – 3 modules

MODULE 1 | 07 November 2023 from 9.30 am to 12.30 pm CET
MODULE 2 | 09 November 2023 from 9.30 am to 12.30 pm CET
MODULE 3 | 14 November 2023 from 9.30 am to 12.30 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: € 945,00* (until 17 October 2023)

Ordinary: € 1.155,00*

Freelance – Academy – Public Administration**: € 615,00*

* 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.