33 computer-security-"https:"-"https:"-"UNIVERSITY-OF-MACEDONIA-RESEARCH-COMMITTEE" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

turn this project will advance safety and understanding of potential toxicity of FDA-regulated products in the perinatal population. Learning Objectives: Under the guidance of the mentor, you will gain

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

: This research project will examine the use of nonclinical in vitro studies to evaluate drug safety and support regulatory decision-making. Research involves using state-of-the-art automated patch clamp

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

and predictive modeling as well as a scientific understanding of the fundamentals of how toxicology study data is used at FDA to ensure the safety of clinical trials. You will also have the opportunity

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Pediatric developmental safety studies in drug

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

. Learning Objectives: Under the guidance of a mentor, the participant will learn about the development of computational models for regulatory use. Research and training activities may include: Learning

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.) Learning Objectives: As a participant, you will have structured learning opportunities in regulatory science, computational toxicology, and

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

research questions involving challenging active/inactive ingredients, sophisticated formulations, and innovative dosage forms; 3) Advanced human subject safety for bioequivalence trials - Conduct meta

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

 contribute to projects that are mandated under the 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from sources other than clinical trials