Introduzione
Mastering Benefit Risk Assessment in Pharmacovigilance
Marketing authorisation holders are required to continuously evaluate the benefit-risk profile of their medicinal products, both before and after market approval. This assessment must integrate regulatory expectations with scientific evidence and the perspectives of patients, prescribers, and healthcare systems.
This course provides a clear and structured overview of qualitative and basic quantitative methods used in benefit-risk assessment. Participants will explore how to interpret data, weigh outcomes, and support decision-making through transparent, consistent, and regulator-ready evaluations.
The programme includes practical examples, hands-on exercises, and updated insights aligned with the recommendations of CIOMS Working Group XII, offering a grounded and modern approach to benefit-risk evaluation.
Programme
During this 2-module course, the following topics will be covered:
Fundamentals of Benefit–Risk Assessment
- Introduction to benefit–risk concepts
- Defining the decision context
- Selecting and prioritising outcomes
- Setting up literature searches
- Data extraction methods
- Study designs: cohort studies, risk ratios, case-control, odds ratio
- Quality evaluation of evidence
- Benefit evaluation principles
- Risk evaluation principles
Quantitative Methods, Frameworks & Practical Decision-Making
- Weighting outcomes and integrating results
- Benefit–Risk metrics (including NNT/NNH)
- BRAT Framework: structure, application and interpretation
- BRAT workshop: hands-on practical exercise
- Interpreting outputs for decision-making
- Taking action based on benefit-risk conclusions
- Final reflections and closing session
Professionals involved in benefit-risk assessment, including those working in:
- Pharmacovigilance
- Medical Affairs
- Clinical Research
- PV Auditing
From:
• Pharmaceutical companies
• CROs / CSOs / consultants
• Biotech companies
Participant experience: Familiarity with GVP Modules I, V, VI and IX is suggested.
The course is highly interactive and includes practical exercises that allow participants to apply the concepts directly. Discussion and exchange of experiences are encouraged to support a collaborative learning environment.
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 | 23 June 2026 from 9:00 am to 01:00 pm CEST
MODULE 2 | 25 June 2026 from 9:00 am to 01:00 pm CEST
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 02 June 2026)
Ordinary: € 1.185,00*
Freelance – Individual – Academy – Public Administration: € 685,00*
* for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Registrati
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.