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… Pharmacoepidemiology and Risk Management Regulatory Real-World Evidence Research Let … evidence to support your development and post-approval activities. To understand disease distribution, risk factors, … other related factors, and the effectiveness of risk minimization interventions, or to evaluate safety and …
… Benefit-Risk Assessment Do your product’s benefits outweigh its … development program and clarify appropriate post-approval activities. This includes: Understanding how a structured … and/or real-world data Implementing additional risk minimization measures, and studies to evaluate their …
… Psychometric Evaluation Our psychometricians have extensive experience … studies to collect data to support psychometric evaluation (independent from clinical trials) Equivalence … psychometric team will help you determine the appropriate evaluation steps and analyses to maximize the value of both …
… Determining Effectiveness of Risk-Minimization Measures Impact of Risk Minimization Measures on … decreased in all study populations, and use of 2 or more antiplatelet drugs decreased in the United Kingdom, …
… address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the effectiveness of risk minimization measures within a risk management plan …
… patterns, impact, and adherence Product safety and risk minimization evaluations (e.g., PASS, REMS) Drug utilization … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… 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 …
… Analysis Methods – Causal Inference 7 February 2024 9:35-10:30 am ET This is the third meeting of the committee; …
… , health economics , and epidemiology and safety activities. Differentiate with Strategic Statistical Data … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… identifying appropriate treatment stopping rules, finding publications reporting stratified cost and utility estimates, …