70 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "UCL" "UCL" positions at Center for Drug Evaluation and Research (CDER)

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

characteristics, toxicology study parameters, and clinical adverse events. Learning Objectives: Under the guidance of a mentor you will gain experiential, applied knowledge concerning both the SEND data standard

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

assess product quality attributes of hormones and develop a comprehensive product quality control strategy for fertility hormones. Learning Objectives: During the appointment, you will be trained in

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

substitutability evaluation. Learning Objectives: Under the guidance of the mentor, you will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

to identify key physiological parameters responsible for altering the PK of LAI in pregnancy and lactation. Learning Objectives: Under the guidance of the mentor(s), the participant will develop the following

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 9 hours ago

to identify where to direct surveillance efforts. Learning Objectives: Under the guidance of the mentor, you will gain knowledge on the development of an analytical method based upon multiple standards

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

), and therapeutic dose selection for IBD. Identify best practices and gaps in dose-selection methodologies to support regulatory decision-making and future pediatric drug development strategies. Learning

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 9 hours ago

dissemination. The participant will regularly present and discuss findings at internal meetings that will include members of NCTR and CDER staff. Learning Objectives: As a participant, you will learn numerous

FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

(DP) plans to re-evaluate these rare safety signals and to determine whether additional regulatory actions are needed. Learning Objectives: Under the guidance of a mentor, you will have the following

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 17 days ago

. Learning Objectives: Under the guidance of the mentor, you will gain comprehensive experience in regulatory biostatistics through hands-on analysis of clinical trial data from FDA submissions in

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

will advance FDA's regulatory science mission and public health objectives while promoting the 3Rs principles (replacement, reduction, and refinement) of animal use during drug development. Learning