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… Pharmacoepidemiology and Risk Management Regulatory Real-World Evidence Research Let … advice ; database or registry study; prospective observational research ; a literature review ; or a risk … companies reduce the uncertainty of risks to patients who use their products. …
… regulators, and prescribers understand the real-world use, value, and safety of your products. Observational … patterns, impact, and adherence Product safety and risk minimization evaluations (e.g., PASS, REMS) Drug … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… study commitments Determining if a post-marketing observational study could address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the … synopses and writing study protocols and analysis plans to use in regulatory discussions Advising on benefit-risk …
… Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, … of patients, physicians, or caregivers. Prospective observational studies can help you: Understand the natural …
… for market segmentation - Provide evidence for possible risk-sharing plans for reimbursement Regulatory Approval - … - Identify evidence for HTA submissions Post-launch Phase IV - Identify additional product value messaging - Identify … working with data sources from clinical trials , observational studies , and registries . …
… Observational Studies Analyzing real-world, observational … using methods such as propensity scores, when estimating risk measures of association. In addition, we assist … that analyses of complex sample surveys require the use of appropriate statistical software that accounts for the …
… Benefit-Risk Assessment Do your product’s benefits outweigh its … your clinical development program and clarify appropriate post-approval activities. This includes: Understanding how a … to evaluate their effectiveness Initiating postmarketing safety studies and/or comparative effectiveness studies The …
… Multinational Observational Study in Chronic Idiopathic Urticaria … measure real-world treatment patterns, healthcare resource use, HRQOL, and indirect burden associated with chronic … APPROACH We conducted an observational, noninterventional, multinational, multicenter study that included a patient …
… PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information … Unapproved Medical Product Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved use dossier, allows you to communicate key product …
… Benefit-Risk Preferences Benefit-risk preference studies are a specific application of … provided with a set of actual treatment options. Benefit-risk preference studies demonstrate the net benefits of … throughout the product development, regulatory, and post-marketing lifecycle. …