Introduzione

Accurate data collection is the essential starting point of the vast process of signal detection.

During this crucial phase, it is vital to evaluate various data sources, each with its own strengths and limitations. The ability to synthesize data from single case reports, case series, scientific literature, and EVDAS into coherent clinical information, is a key competency for professionals in pharmacovigilance. At the same time, it is crucial to monitor the practical implementation of signals and ensure that the entire critical process fully meets regulatory expectations.

This course provides participants the opportunity to gain a comprehensive and in-depth understanding of signal investigation and management.

Starting from regulatory authority expectations, participants will follow a guided pathway that, step by step, will enable them to:

– Apply targeted products strategies
– Adopt scientific investigative methods for data evaluation
– Understand statistical methods of disproportionality
– Recognize the relationships between signals and risks
– Monitor the implementation of signals in product labeling
– Identify process indicators (KPIs)
– Be better prepared for audits and inspections.

The discussion includes future amendments to the Commission Implementing Regulation 520/2012 and will be enriched with practical exercises, including the analysis of eRMR, offering the chance to apply the concepts learned.

The following topics will be covered across the 3 modules:

– Operation of EVHUMAN with specific reference to EVDAS outputs
– Regulatory requirements for Signal Management
– Product strategy definition for Signal Detection, with practical exercises/simulations
– Various signal investigation methods
– Evaluation of scientific literature: search criteria, quality assessment and bias, with practical exercises
– Qualitative analysis: single case and case series analysis
– Causality assessment
– Confounders
– MedDRA SMQs: introduction, examples, and usage
– Signal validation with examples of different situations
– Disproportionality measures
– EVDAS operations and interface
– eRMR analysis
– Practical exercise/simulation of eRMR analysis
– Management of confirmed signals: from signal to labeling
– Monitoring of variations implementation
– Process performance indicators
– Regulatory compliance in audits and inspections

Pharmacovigilance personnel involved in signal management, auditors in pharmacovigilance, from:

– Pharmaceutical companies
– Service providers (CRO, CSO, service providers, consultants)
– Biotech companies

Participant experience: it is recommended to have knowledge of the relevant GVP guidelines (Modules I, VI, V, and IX) and at least 2 years of experience in pharmacovigilance.

 

The course is highly interactive and includes practical parts where participants will actively apply the knowledge they have acquired.

There will be ample room for discussion with the audience about the complexities encountered, possible solutions, and exchange of ideas.

Docente/i
Francesco Tescione
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.

 


This online training is divided in 3 modules:

MODULE 1 | 23 September 2025 from h.02:30 to h.05:30 PM CEST
MODULE 2 | 25 September 2025 from h.02:30 to h.05:30 PM CEST
MODULE 3 | 30 September 2025 from h.02:30 to h.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: € 975,00* (until 02 September 2025)

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

Registrati
Early bird
Acquistabile fino al 02/09/2025
975,00
Ordinaria
Acquistabile fino al 20/09/2025
1.185,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 20/09/2025
685,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Fully understand what is required for a signal detection and management process that meets regulatory requirements
Risultato atteso
Apply appropriate investigation methods for data sources for effective signal detection
Risultato atteso
Understand how to use EVDAS and eRMR
Risultato atteso
Know how the processes of signal reporting, pharmacovigilance signals, and safety risks are interconnected
Risultato atteso
Acquire practical examples for implementation in the company

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>