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11 June 2025

Chair: Marco Boeri
This session is a joint effort of the EFSPI/PSI Benefit-Risk ESIG. The speakers will emphasize recent developments in BRA methodologies for medicinal products.

What does the CIOMS WG XII Benefit-Risk Assessment Report say? - Shahrul Mt-Isa
Innovative trial designs and effect size estimation - bias, de-biasing, and when is it considered to be important - Ursula Garczarek
Implementing innovative safety evaluation methods: Overcoming challenges and sharing successes - Naomi Givens
Methodological aspects and practical application of a drug quantitative benefit-risk assessment: a case study - Zhaoyang Teng, Hua Liu, Zhaowei [Zoe] Hua, Rui [Sammi] Tang and Gaëlle Saint-Hilary

Shahrul Mt-Isa, Ursula Garczarek Naomi Givens and Pavel Mozgunov

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