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2020 FDA Patient-Reported Outcomes Guidance Draft On August 31, 2020, the FDA released its draft guidance titled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” …
… Alejandro Vanegas Surveys and Observational Studies Telecommuter - USA MS, Epidemiology Columbia … Mailman School of Public Health, New York, NY BA, History New York University College of Arts and Science, New … a Senior Project Manager in the Surveys and Observational Studies group at RTI-HS. Mr. Vanegas has over a 15 years of …
… discoverability and study replicability in observational studies) is launched Ensuring patients can trust the safety … trials, EMA seeks to employ information from observational studies designed to understand the use of medications in …
… Survey, and the Healthcare Cost and Utilization Project family of databases) to estimate the prevalence of various medical conditions and their associated economic burden. Dr. Candrilli has coauthored …
… in these analyses. Researchers identified and reviewed studies reporting utility values for different MDD health states. They found that the reviewed studies included diverse populations and clinical definitions …
Xabier Garcia de Albeniz Martinez Pharmacoepidemiology and Risk Management Barcelona, Spain MD, Medical University of Navarra, Pamplona, Spain Clinical Oncology Hospital Clinic, Barcelona, Spain ScM, Biostatistics Autonomous University of Barcelona, …
… of child neurodevelopment, including longitudinal studies performed in Spain on brain development and air … school children and European collaborative cohort project studies within the European FP7 and Environmental Health … School. In addition, Dr. Forns has been involved in cohort studies, case-control studies, meta-analyses, and multiple …
… expertise in the planning, design, and execution of studies. Dr. Kawai has 13 years' experience as a … including post-authorization safety and other regulatory studies. She has worked extensively in multi-site … in conducting feasibility assessments and validation studies. Dr. Kawai has worked in a range of therapeutic and …
… a project director and manager for a variety of research studies, including trial designs and epidemiologic research … has focused on safety studies evaluating disease natural history and incidence of and risk factors for rare adverse outcomes potentially associated with use of medications. These studies span the …
Highlights From AMCP 2024 on the New Dossier Format Version 5.0 Share on: May 1, 2024 Image Contributor: Jennifer Alkire, PharmD, Senior Associate, Value & Access, RTI Health Solutions Jennifer attended the AMCP 2024 conference and brings back these …