75 machine-learning-"https:" "https:" "https:" "https:" "https:" "https:" "NORTHUMBRIA UNIVERSITY" positions at Center for Drug Evaluation and Research (CDER)

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 15 hours ago

. Learning Objectives: Under the guidance of the mentor, you will develop the following skills during the fellowship; Develop advanced information search strategies to identify and organize data relevant

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 | about 15 hours 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 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 | about 15 hours 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

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 15 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 15 hours 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 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 15 hours 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 - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 15 hours ago

product characteristics on the effectiveness of search strategies. Learning Objectives: You will learn best practices in drug and biological product post-market safety surveillance and receive hands

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 15 hours ago

activities related to the research project: participate in data collection from public and proprietary sources, analyze research data, and contribute to presentation/publication of research findings. Learning

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 15 hours 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 | about 15 hours 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