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… attributes. Takeaway 6: Consider developing a section on treatment landscape and unmet need Although not specified in … guidance for development of a UPD or UUD, describing the treatment landscape for the indication can help the payer … data as it becomes available. A high-quality UPD can be used as the foundation for the post-approval dossier. …
… analysis and reporting of regulatory observational drug safety studies involving different data collection methods … the effectiveness of risk minimization measures of drugs involving multinational sites. Ms. Gutiérrez has … Her primary research areas of interest include studies on evaluation of cancer-related outcomes associated with the use …
… Pharmacoepidemiology and Risk Management Rheumatology Diabetes & Endocrine Disorders Cardiovascular Barcelona, … including leading multidata source postauthorization safety studies (PASS). He has led research projects involving … Dr. Pladevall-Vila received and completed research grants from the National Institute of Diabetes and Digestive …
… Mauskopf has extensive experience implementing economic evaluation programs for drugs or vaccines for bacterial infections, viral infections, … and the other to develop guidelines for the economic evaluation of vaccination programs. As a highly-respected …
… New Real-World Evidence of Effective Treatment in Non-Small-Cell Lung Cancer with Capmatinib Share … Focus The study focused on patients who had received treatment with the MET inhibitor capmatinib, which gained … response rate as well as the duration of response, time-to-treatment discontinuation, disease control rate, and …
… databases to address regulatory agency-required pregnancy safety studies, evaluation of risk management plans, approaches to … epidemiologic evidence contributing to the development of drugs prior to marketing; the pharmacovigilance of marketed …
… access for vaccines to prevent various diseases. Recent project types have included: Benefit-risk preference studies … prevalence, and natural history estimation Research on safety and efficacy, and to support regulatory requirements … Reimbursement dossiers (i.e., AMCP) Survey development, evaluation and implementation Value communication strategies …
European Crohn's and Colitis Organisation (ECCO) 2024 Share on: Wednesday, February 21 - Saturday, February 24, 2024 Conference website Research coauthored by RTI Health Solutions experts will be presented at the European Crohn's and Colitis Organisation …
… experience in the rigorous development and psychometric evaluation of clinical outcome assessment measures for use in … to develop and evaluate remote access versions of a widely used clinical outcome assessment in ALS as part of the …
… uptake. Real-World Insight: Imagine you have a novel treatment for a chronic disease. Early discussions with … product’s appeal. 2. Map Prescribing Pathways for Current Treatment Options Why it Matters: Understanding what competing drugs exist and how they are being prescribed helps position …