Training Signal Detection and Signal Management

Introduzione

Signal Detection and Signal Management

Signal detection is a cornerstone of pharmacovigilance and requires a robust, structured, and scientifically sound approach. Effective signal detection begins with accurate data collection and a clear understanding of the strengths and limitations of different data sources. Today, professionals must be able to integrate information from individual case reports, case series, scientific literature, and EVDAS outputs into meaningful clinical assessments—while ensuring that each step of the process remains compliant with regulatory requirements.

This course provides a comprehensive and up-to-date overview of signal investigation and signal management, incorporating the latest changes introduced by Commission Implementing Regulation (EU) 2025/1466. Through a combination of theory, guided discussions, and practical exercises, participants will strengthen their ability to detect, validate, assess, and manage safety signals within a compliant and efficient framework.

Programme

Starting from regulatory expectations, participants will follow a structured and practice-oriented pathway designed to enhance their ability to:

Apply product-specific strategies in signal detection
Adopt scientific and methodological approaches for evaluating data sources
Understand disproportionality analyses and related statistical concepts
Recognize the relationship between signals and identified/confirmed risks
Monitor the implementation of signals in product information
Identify and interpret process indicators (KPIs)
Confidently prepare for audits and inspections

The course also explores future amendments to Commission Implementing Regulation 520/2012. Each module includes hands-on exercises—such as eRMR analysis—to help participants immediately apply what they learn.

Topics covered across the three modules include:

Operation of EVHUMAN, including EVDAS outputs
Regulatory framework for signal detection and signal management
Definition of product strategies, with practical simulations
Scientific literature evaluation: search strategy, quality assessment, bias (with exercises)
Qualitative analysis of single cases and case series
Causality assessment and confounding factors
Use of MedDRA SMQs: introduction, examples, and practical applications
Signal validation approaches and real-world scenarios
Disproportionality methodologies
EVDAS navigation and interface
eRMR analysis and practical simulation
Management of confirmed signals: from signal to labeling
Monitoring the implementation of variations
Process performance indicators
Regulatory compliance in audits and inspections

This course is designed for pharmacovigilance professionals involved in signal management and for auditors working in PV, including those from:

Pharmaceutical companies
Service providers (CROs, CSOs, consultants)
Biotech companies

Participant experience

Familiarity with GVP Modules I, V, VI, and IX and at least two years of experience in pharmacovigilance are strongly recommended.

The training is highly interactive and combines theoretical content with practical application. Participants will be encouraged to share experiences, discuss challenges, and collaboratively explore solutions. Hands-on activities and guided exercises ensure a strong connection between learning and real-world application.

Docente/i

Info

Francesco Tescione

European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C.

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.

Durata e Informazioni utili
Quote Iscrizione

This online training is divided in 3 modules:

MODULE 1 | 22 September 2026 from 02:30 pm to 05:30 pm CEST
MODULE 2 | 24 September 2026 from 02:30 pm to 05:30 pm CEST
MODULE 3 | 29 September 2026 from 02:30 pm to 05:30 pm CEST

Some days before the online training 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: € 985,00* (until 01 September 2026)

Ordinary: € 1.195,00*

Freelance – Individual – Academy – Public Administration: € 685,00*

* for Italian companies: +22% VAT

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