Search
Use the filters to narrow by type of content
Looking for a Publication? Search the bibliography for: publications fundamentals us regulatory affairs
… with the sole objective of advancing medical device regulatory science throughout the total product life cycle. …
… avoid duplication of efforts, and promote technical, regulatory, and commercial collaboration in pursuit of …
… disease risk factors, and safety; supported sections of regulatory submissions and risk management plans; and … has also coordinated epidemiology activities to prepare regulatory documents on benefit-risk review for various …
… capmatinib, which gained accelerated approval from the US FDA in 2020. To provide context to the results, … for this real-world study were collected from across the US, via a retrospective medical record review, and captured …
… in the design, implementation, analysis and reporting of regulatory observational drug safety studies involving … and pediatric investigation plans required for regulatory submissions. Before joining RTI-HS, Ms. Gutiérrez …
… Identifying an unmet need in the market and meeting regulatory requirements is only half of the commercialization … picture. All too often we see manufacturers focus on the regulatory pathway and underestimate the reimbursement and …
… outcomes assessments in prospective trials for regulatory submission and as postmarketing studies. Her areas … data, publication development, and outcomes-related regulatory submission strategies. Ms. Mordin's therapeutic … Mordin regularly presents at conferences and has numerous publications in peer-reviewed journals, including the Journal …
… for Diversity rankings resulted from surveying 170,000 US employees RESEARCH TRIANGLE PARK, N.C. — Nonprofit …
… Health Economics HTA and Reimbursement Submissions Regulatory Guidance and Support Staff Members Emma Hawe …
… practice, provide critical insights, and help inform regulatory decisions. Image EMA has recently launched the …