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… and Outcomes Strategy at RTI Health Solutions FDA Guidance In June 2018, the United States Food and Drug Administration (US FDA) released an important … prefer to receive information from manufacturers well in advance of a product’s approval by the FDA so that they …
… attended the AMCP 2024 conference and brings back these insights. The Academy of Managed Care Pharmacy (AMCP) … for Formulary Submissions (AMCP Format) was introduced in 2000 and has been updated several times since then. The … seeking reimbursement and/or formulary placement in the US healthcare system for new pharmaceuticals, …
… Full Article: Transparency and Reproducibility in Real-World Evidence (RWE) Generation Regulatory real-world … evidence (RWE) needs to be transparent and reproducible. In collaboration with our research partners, we’ve been … across studies that use different data sources. Even in multidatabase studies, where we can use approaches to …
… Access and Outcomes Strategy Telecommuter - USA MSc, Food Science and Human Nutrition BA, Technical Journalism and … Collins, CO Stephanie MacLeod has extensive experience in scientific writing, communications and research roles in healthcare, pharmaceutical, biotechnology, and higher …
… University of Barcelona, Barcelona, Spain Certificate in Computer Information Systems Portland Community College, … Management at RTI-HS, with over 19 years of experience in the pharmaceutical industry with the coordination and … many leading research institutions in Europe and North America and other multi-country collaborative projects and …
… Glasgow, United Kingdom Alan Fleming has experience in working with longitudinal registry data and with combined … trial databases for survival analyses, specifically in the therapeutic area of diabetes. His work in medical … to medical device regulatory applications to the Food and Drug Administration (FDA), and generated patents. …
… Associate Director and Senior Clinical Research Associate in the Projects and Proposal Operations Division of RTI-HS. … played a project management and monitoring leadership role in a number of clinical and patient centered outcomes … regulatory review, data management, IRB management, Food and Drug Administration regulation and International …
… - USA BS, Biology Indiana University, Bloomington, IN Daniel Wolin is a Senior Director in the Surveys and Observational Studies group at RTI-HS … and cell therapy (autologous). Mr. Wolin has led numerous Food and Drug Administration meetings (pre-IND, end of phase …
… Upper Montclair, NJ Tammy Lesko, is Senior Director in the Office of Quality at RTI Health Solutions and … with over thirty years’ experience. She has experience in Sponsor companies, multiple Contract Research Organizations, an independent IRB, the US Food and Drug Administration and a generic pharmaceutical …
… data to enhance programs and assess treatment outcomes in both physical and mental health settings. Her experience … and validation of clinical outcome assessments for use in clinical trials across a range of indications (e.g., … patient-focused drug development guidance authored by the Food and Drug Administration (FDA). …