ISOP 2021 SATELLITE TRAINING COURSES 

Pre – conference course I – Nov 01Pre – conference course II – Nov 02 & 04Post – conference course III – November 18
Pharmacoepidemiological Methods in Pharmacovigilance (in collaboration with Drug Safety research unit – DSRU)Managing Safety Signals in Daily Practice – A Challenge for License Holders and Health AuthoritiesMaking and Assessing Periodical Benefit-Risk Evaluation Reports (PSUR – PBRERs)
Responsible: Saad ShakirResponsibles: Eugene van Puijenbroek and Mulugeta RussomResponsible: Jean-Christophe Delumeau
Course I - Outline
The training will provide an overview of the methods and approaches used in pharmacoepidemiological analysis of big observational datasets. Strengths and weaknesses of such analytical approaches will be explained, and the main sources of data presented. Benefits of combining such population-based analyses with patient focused and clinical analyses used in pharmacovigilance will be discussed.

This course will be organised online on November 01 according to 4 sessions, including lectures, Q&As, and panel discussions.

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Course II - Outline
Pharmacovigilance activities generate new signals of possible drug related problems from many different sources and of varying quality and strength. This course will discuss how to validate and confirm safety signals and how to decide what actions to take and when. Representatives from regulators and industry will give perspectives of their respective roles and responsibilities in informing healthcare professionals and patients about new safety information.

This course will be conducted online on November 2 and 4. Each of those two days will be composed of 2 sessions of 120 minutes each, including lectures and practicum, separated by 30-minute intermissions for relaxing.


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Course III - Outline
In the context of global regulatory strengthening, an increasing number of National Regulatory Authorities (NRAs) request receiving Periodic Benefit-Risk Evaluation Reports (PBRERs). This results in a substantial additional burden for both NRAs and License Holders requested to generate additional documents according to country-specific timelines. This course will be addressing the challenges faced for scheduling, making, and assessing PBRERs in a global context no longer limited to Health Authorities members of the ICH organisation.

This course will be organised online on November 18 according to 3 sessions, including lectures, Q&As, and panel discussions. The agenda will include: a) The methods and practices for Assessing Benefits versus Risks and Uncertainties, b) The PBRER concept, its making and distribution in a global context, c) and the PBRER assessment methods and practices. The event will be ending with a panel discussion on “How to transfer PBRER review know-how to National Regulatory Authorities starting to request reviewing them. How to facilitate, support, take advantage from reliance and work-sharing”.


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MORE INFORMATION AND PROGRAMME AVAILABLE HERE

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