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

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

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

the results of the project and their conclusions to the DCP and/or a broader clinical pharmacology audience. Contribute to a manuscript regarding the results of the project. Learning Objectives: During

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 | 2 days ago

addresses the need to improve data collection in pregnant and lactating women. Learning Objectives: This appointment provides structured learning through FDA courses and training on drug development topics

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

industry submissions. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning opportunity. You will receive

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

variety of advanced analytical and bioanalytical assays from method development to experimental or test sample analysis including the process of method validation. Learning Objectives: Computational

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

. Learning Objectives: Under the guidance of a mentor, you will: Gain foundational knowledge of pharmacovigilance and AI application: you will learn the key elements of adverse event case definition and how it

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

. Contribute to a manuscript regarding the results of the project. Learning Objectives: The fellow will gain regulatory science experience and policy development insight that supports advancement in clinical

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

generic products to support bioequivalence and product development. Learning Objectives: Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 1 day ago

for these impurities in various drug products. Learning Objectives: Under the guidance of the mentor, the participant will gain knowledge, expertise and experience in pharmaceutical analysis, specifically in

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

that provide clarity on distinguishing transporter-mediated creatinine elevation from true nephrotoxicity in drug development and regulatory review. Learning Objectives: Educational activities will at least

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

the change in individual level of immunogenicity over time and the change in population level internally and externally Learning Objectives: Through participation in this research opportunities, the you will