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
Francesco is responsible for the pharmacovigilance system through the coordination of all pertinent aspects, including quality and risk management. With a background in Pharmacy and a Master’s in Clinical Epidemiology and Guidelines, he has served as Eu-QPPV for about 20 years. He has published several papers in international journals on topics such as the predictability-avoid ability of adverse reactions and methods for determining the causal association. He has been a speaker at several training events on various aspects of Eudravigilance, 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 1 November 2024)
Ordinary: € 1.185,00*
Freelance – Individual – Academy – Public Administration**: € 685,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – 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.
Newsletter
Francesca Archetti
Marketing & Sales Specialist
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
