Search
Use the filters to narrow by type of content
Looking for a Publication? Search the bibliography for: publications fundamentals data management 3
… will the product influence the clinical pathway? Are there data that can be leveraged at launch to influence … and costs impact pricing potential? How can affirmative data (e.g., FDAMA Section 114) be generated? Pricing & …
… or coauthored more than 450 peer-reviewed scholarly publications. He is a former president of the Society for … new role.” Related Services Pharmacoepidemiology and Risk Management Staff Members Kenneth J Rothman …
… Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. … conducted a cohort study using nationwide Swedish Registry data. The study included over 5,000 women who used …
… in Rotavirus Vaccination Coding in US State Medicaid Data Layton JB , Butler AM, Brookhart MA, Panozzo CA … to accurately identify exposures of interest in real-world data. US Medicaid data could be a good option for research on the use, …
… from regulatory agencies include studies with prospective data collection and studies that make secondary use of existing data sources—using real-world data to generate real-world evidence (RWE). We have …
… Request (ICR) form, which manufacturers use to submit data to CMS in support of their products. Introducing the … product compared with therapeutic alternatives. These data elements were revised in a new ICR form for IPAY 2027 … development, status of relevant patents, and sales volume data. The optional elements of the ICR form are discussed in …
… open input period, where stakeholders provide relevant data, was introduced in 2016. We found that most of the … base-case analyses were recommendations to use specific data or methods and concluded that it is crucial for …
… to address this challenge by integrating expertise and data from multiple European Research Centres. The new … Related Services Pharmacoepidemiology and Risk Management Staff Members Susana Perez-Gutthann Carla Franzoni …
… Episheet Spreadsheets for the Analysis of Epidemiologic Data Episheet is a spreadsheet workbook that evolved from a … Jr.) It comprises various analyses for epidemiologic data, including confounding control by stratification of rate data, risk data and case-control data, study size and power …
… milestones across the studies, while meeting deadlines for publications. OUR APPROACH We assembled a core team of …