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As part of EFSA’s commitment to transparency, identifying and characterizing uncertainties and explaining their implications for assessment conclusions is an important element of EFSA’s risk assessment process. The EFSA guidance on uncertainty analysis in scientific assessments brings more clarity on how it can be performed in a structured, transparent and unambiguous way. This online tutorial will enhance the understanding and enable the practical implementation of the guidance document on uncertainty analysis in scientific assessments.

The focus of this course is on giving an overview of EFSA´s principles and processes for risk assessment of non-applicant mandates elucidating the different steps by recent and educational examples.

The final step of the process of risk-benefit assessment of foods is the integration of estimated risks and benefits that have been identified through the process. Because health effects associated with a specific food or food components vary in terms of disease manifestation, severity, duration, incidence and mortality, it is often necessary to apply a summary measure of population health metric to combine impacts in a single measure. While there are various metrics available, this course will focus on the widely used Disability Adjusted Life Years (DALY) as common health metric to express health impact. With a “hands-on” process, participants will gain an understanding of the steps to perform the final step of an RBA and calculate DALYs. The specific contents and examples of the course will be adapted to reflect the multi-disciplinary of the tool.

Risk-benefit assessment (RBA) of foods is a decision-support tool that assesses the combined beneficial and adverse health effects of foods, diets or food components. It integrates knowledge on nutrition, toxicology, microbiology, and human epidemiology for comprehensive health impact assessments. RBA is thus useful to inform food safety policies or to provide dietary advice based on an integration of the available scientific knowledge. This course provides an introduction to microbiological risk assessment and to toxicological risk assessment in the context of risk benefit assessment, discusses the differences and commonalities between the two methodologies, and explains how the output of the two methodologies (seen as components as RBA) are integrated for a final quantitative assessment of risks and benefits of foods. The training will include practical exercises and examples to illustrate applications of these methods.

The focus of this course is to give an overview on the EFSA´s guidance on the use of the weight of evidence (WoE) approach in scientific assessments.

Non-applicant mandates for risk assessment by EFSA are expected to follow EFSA´s guidance on principles and processes. The draft guidance for protocol development has recently been presented and several projects already followed the general rules described therein. Two out of the four online seminars of this training will focus on the different guidances involved in protocol development.

The international gathering of biopharma professionals BIO-Europe® will take place in Munich, Germany, from November 6 to 8, 2023. Meet our representatives of Fraunhofer health research at the joint booth of the Fraunhofer Group for Health Research.