About
Signal Detection & Management: From Data to Regulatory Action
Effective signal detection and management goes beyond identifying potential safety concerns. It requires the ability to critically evaluate data from multiple sources, interpret emerging evidence and translate findings into scientifically sound, timely and compliant regulatory actions.
From individual case reports and scientific literature to EVDAS outputs, each source presents specific opportunities and challenges. Understanding how to integrate and assess this information is essential to making informed decisions throughout the signal management process.
This course provides a structured, practical approach to the entire signal management lifecycle, from detection and validation to assessment, regulatory action and follow-up.
Combining regulatory requirements, scientific methodologies and hands-on exercises, the training will help participants strengthen their analytical and decision-making skills, understand the implications of the evolving EU regulatory framework, including amendments to Commission Implementing Regulation (EU) No 520/2012, and apply effective signal management practices in their daily work.
Programme
The following topics will be covered across the 3 modules:
Regulatory Framework and Signal Detection Strategies
- EU regulatory framework for signal detection and management, including Commission Implementing Regulation (EU) No 520/2012 and its amendments under Regulation (EU) 2025/1466
- EVHUMAN operations and EVDAS outputs
- Defining product-specific signal detection strategies through practical simulations
Evaluating Safety Data and Identifying Potential Signals
- Scientific literature: search strategies, quality assessment and potential bias
- Qualitative analysis of individual cases and case series
- Causality assessment and confounding factors
- MedDRA SMQs: principles, examples and practical applications
From Signal Detection to Validation
- Approaches to signal validation and practical scenarios
- Disproportionality analysis: principles and methodologies
- Navigating EVDAS and interpreting its outputs
- eRMR analysis and hands-on exercises
Managing Confirmed Signals and Regulatory Actions
- From confirmed signals to product information updates
- Understanding the relationship between signals and identified risks
- Monitoring the implementation of regulatory variations
Monitoring Performance and Ensuring Compliance
- Defining and interpreting signal management KPIs
- Preparing for pharmacovigilance audits and inspections
- Addressing regulatory compliance challenges in signal management
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.
Lecturers
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.
This online training is divided in 3 modules:
MODULE 1 | 21 September 2027 from 02:30 pm to 05:30 pm CEST
MODULE 2 | 23 September 2027 from 02:30 pm to 05:30 pm CEST
MODULE 3 | 28 September 2027 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: € 995,00* (until 31 August 2027)
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.
Register
Accepted payment methods: Bank Transfer, Credit Card, PayPal.
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.