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… researchers across therapeutic fields to plan and develop publications highlighting their work. Key research fields and … 2 novel glycosyltransferases and exploring their function within mammalian development of the heart, lungs, …
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward Emma Hawe, MSc Head, Data Analytics and Design Strategy RTI Health Solutions Transcript: What Do We Need to Know About Joint Clinical Assessments (JCAs)? …
… EMA to negotiate acceptability of COA-based endpoints for use in label claims, as well as guiding industry clients …
… Directors and the Special Interest Group of Medications in Pregnancy. …
… The focus of recent projects that she has led include the use of databases to address regulatory agency-required pregnancy safety studies, evaluation of risk management …
… focus on considerations for noninterventional studies that use RWD and are intended for regulatory submission. The … data integrity and selecting data that are fit for use, and the importance of providing FDA access to …
… Food and Drug Administration (FDA) strongly encourages the use of PROs in clinical trials to accurately assess treatment …
… based on COA endpoints Gap analysis of data supporting the use of COAs for your intended purpose Collection of …
Uncovering Factors Associated with Adult Vaccination Coverage in the US Share on: April 28, 2021 Adult vaccination rates in the US are generally low and fall short of public health goals. Given the human and economic burden of vaccine-preventable …
… area Develop economic model inputs including resource use, cost, and utility estimates Identify health disparities …