72 data "https:" "https:" "https:" "https:" "UNIVERSITY OF RIJEKA" positions at Center for Drug Evaluation and Research (CDER)

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

efficacy in children often based on data in adults based on assumptions or evidence of disease and response similarity between adults and children. The critical need to systematically assess extrapolation

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

electrophysiology to assess mechanisms of drug effects on cardiac and neuronal ion channels critical for safety evaluation. Additionally, the research will include advanced statistical modeling for data analysis and

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 6 days ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: You will join a project to analyze data for CDER drug premarketing applications housed in internal regulatory

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

, including biological therapeutics and generic drugs. This effort covers more than just medicines. Research Project: CDER has recently begun storing both electronic toxicology study data and nonclinical

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

prevalence data, and evaluating ineligibility rates by race and ethnicity. The project will examine at least 20 drugs/trials and may stratify analyses by U.S. versus non-U.S. sites. Learning Objectives: You

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support