Pre-conference courses

Pre-Conference Course 1

Advanced signal detection

09:00–17:00

Room T3

Signal detection is one of the main activities of Pharmacovigilance. The approach to signal generation, refinement, and confirmation has evolved over years, opening new frontiers of debate about the roles of different stakeholders in the process and the need for an implementation of regulatory frameworks, publication rules, and risk communication strategies. In 2021, the circumstances of the approval of COVID-19 vaccines were exceptional and provided an unprecedented challenge for signal detection that deserves to be studied in-depth. This one-day pre-conference course will illustrate the process of signal detection using a step-by-step approach, starting from basic elements and concluding with discussion on the most current challenges being faced.

Chairs: Marco Tuccori (University of Pisa, Italy) and Ugo Moretti (University of Verona, Italy)

Pre-Conference Course 2

Introduction to pharmacoepidemiology studies and their role in Pharmacovigilance

09:00–12:45

09:00–12:45

Room T2

The aim of this half-day course is to provide a basic understanding of the concepts and practice of pharmacoepidemiology. You will learn about the fundamentals of pharmacoepidemiology, its practical uses and its limitations, as well as how pharmacoepidemiology and pharmacovigilance can be used together to inform medicines safety.

By the end of the course, participants should be able to:

• demonstrate an understanding of basic study designs commonly used in pharmacoepidemiology

• gain an understanding of fundamental statistical concepts

• be familiar with potential sources of error and the limitations of pharmacoepidemiological studies

• understand how data from pharmacovigilance and pharmacoepidemiology can be synthesized into evidence of safety

Chair: Rebecca Chandler (ISoP Vice-President, Coalition for Epidemic Preparedness Innovations, Sweden)

Co-Chairs:Gianmario Candore (Bayer, Germany) and Houda Sefiani (Moroccan Pharmacovigilance Centre, Rabat WHO Collaborating Centre, Morocco)

Pre-Conference Course 3

Regulatory Updates across the Continuum of Spontaneous Reporting to Risk Minimization

13:30–17:00

Room T2

This half-day course will address regulatory challenges and ‘state-of-the-art’ methodological approaches to current issues across the continuum of spontaneous reporting to risk minimization.

With a multi-region focus, learn about how the QPPV role has evolved to deal with increasingly complex pharmacovigilance regulations; hear from EMA speakers about the EU’s novel analytical methodologies in signal detection and risk assessment and methods for effectiveness evaluation of risk minimisation measures (RMMs); and learn about how Morocco is prioritizing multi-stakeholder involvement in risk management planning and implementation on a local level.

There will be plenty of time for Q&A and we look forward to lively discussion.

Chairs: Deirdre McCarthy (ISoP Executive member, Gates MRI, USA) and Giampiero Mazzaglia (Milano Bicocca university, Italy)