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Workshop on Clinical Benefit-Risk Methodology and Templates

August 3, 2022
Zoom

DCVMN Workshop on benefit-risk methodology and templates

03 August 2022, from 10 am to 12 pm, to be held by Zoom

Speaker: Dr. Pieter Neels, Vaccine Advice, Belgium

The last 20 years the regulatory authority bodies have been struggling with how an objective evaluation of a medicine can be made. Therefore the paradigm of Benefit/Risk has been developed: weighting up the clinical benefits versus the risks. This is based on the evaluation of a large amount of data, to aid regulatory decisions on the acceptability and regulation of medicinal products. This weighting is based on certainties (Evidence-Based Medicine) and uncertainties: extrapolation of what we know to what we don’t know. To date, however, there is no standard methodology to be used. To help address this, the EMA in collaboration with experts in decision models from the London School of Economics and Political Science (LSE) and with the University of Groningen, published a guidance document incorporating a number of improvements in the way assessment reports can structure the outcomes of clinical benefit-risk assessments, for consideration.
Dr. Neels will “walk through” available documents and templates, and will provide explanatory information on each point, as well as examples, and answer questions from the audience.
The virtual workshop is open to professionals working on Clinical Development, Pharmacovigilance, Regulatory and Medical Affairs units, who are welcome to attend.
Background information related to this topic is also available at the related EMA webpage Benefit-risk methodology-European Medicines Agency (europa.eu).

Documents
Benefit Risk e-learning slides
day-80-assessment-report-overview-d120-loq-template-guidance-rev0821_.pdf