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… Applications, Pediatric Investigation Plans, Environmental Risk Assessments), pharmacovigilance, and risk management plans. They help you understand: … Natural history Measures of disease frequency Risk factors and comorbidities Clinical practice patterns …
… to enable multi-country studies using common analyses to study responses to treatments in large populations. SIGMA … groups and networks. The SIGMA Consortium is formed by a group of leading research institutions and Universities with … Related Services Pharmacoepidemiology and Risk Management Staff Members Susana Perez-Gutthann Carla …
… MINERVA project (Metadata for data discoverability and study replicability in observational studies) is launched … and Medical Devices (AEMPS), Spain Spanish Working Group on Chron’s Disease and Ulcerative Colitis (GETECCU), … Netherlands Related Services Pharmacoepidemiology and Risk Management Real-World Evidence Staff Members Susana …
… Xabier Garcia de Albeniz Martinez Pharmacoepidemiology and Risk Management Barcelona, Spain MD, Medical University of … the University of Barcelona and a Master of Science with a concentration in Epidemiology from the Harvard School of … and methodologic expertise to RTI-HS's Epidemiology group. …
… orphan drugs approved for only one disease or condition, plasma-derived products, and small biotech drugs. Drugs with …
… health illnesses. Recent projects have included: Benefit-risk preference studies Decision-analytic models (cost …
… economic, PRO /QoL value A Roadmap: Tactical project and study recommendations for filling the gaps Market Access …
In-Person Course: Regulatory-Grade Causal Inference in Health Research Share on: Wednesday, March 12, 2025, 3pm - Friday, March 14, 2025, 1pm Learn to Use Target Trial Emulation for Regulatory Real-World Evidence Generation Presented by RTI Health …
… among members of the ISPE Databases Special Interest Group, we helped conduct a scoping review to identify … to enable the uniform implementation of self-controlled study designs across a federated network of data sources. The self-controlled case series and self-controlled risk interval designs are part of the arsenal of tools that …
… of dementia: a target trial emulation. Transcript Our study evaluated whether the use of antidepressants with … to 3 different treatment strategies on the 12-year risk of dementia. The first two strategies involved the … was included to reduce confounding by indication. The study design appropriately handled treatment-confounder …