Benefit-Risk Assessment, Communication, and Evaluation (BRACE)

(A-020) A cross-sectional analysis of Patient-Reported Outcomes collection in registries indexed in the Heads of Medicines Agencies-European Medicines Agency Catalogues of Real-World Data Sources and Studies

(A-027) Design and User-Testing of Digital Additional Risk Minimisation Material

(A-024) Evaluating Clinical Benefit and Regulatory Approval Patterns of Newly Approved Therapies for Multiple Myeloma: Is Brazil Keeping Pace with Global Advances?

(A-026) Identifying opportunities and challenges in the use of real-world data to support the ongoing benefit-risk evaluation of new treatments for Alzheimer’s Disease

(A-025) Is there an impact of menstrual cycles on chronic diseases outcomes?

(A-022) Opening the DOOR for Patient-Centric Benefit-risk Evaluation:Highlights from the CIOMS Benefit-risk Working Group

(A-031) Patient-reported adverse events and subjective severity and impact among patients diagnosed with non-small cell lung cancer (NSCLC), renal cell cancer (RCC), colorectal cancer (CRC), and metastatic melanoma

(A-028) Patient-reported outcomes in dermatological medicines: An overview of EU marketing authorizations from 1998 to 2024

(A-019) Patients’ and Caregivers’ Understanding of the Serious Risks of Opioid Analgesics and How to Use These Products Safely: A Patient/Caregiver Survey

(A-032) REMS Registries: The Role They Play & How They Operate

(A-021) Risk Minimization Strategies for Preventing Prenatal Exposure to Teratogenic Medications: Evaluating the Evidence

(A-023) Studying paternal drug exposures and offspring outcomes: feasibility assessment of large European databases

(A-029) Transparency in the Training, Validation, and Testing of Artificial Intelligence-Based Tools for Real-World Evidence Synthesis

(A-030) Use of Real-World Evidence to Satisfy U.S. FDA Postmarketing Requirements and Commitments