32 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "UCL" "UCL" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

be utilized to test unstressed and stressed FSH, LH and hCG samples, comparing their performance with the current in-use rat potency assays. Learning Objectives: During the appointment, you will have

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

knowledge base is dispersed and “hidden” in different parts of the Agency. Learning Objectives: Under the guidance of the mentor, the participant will train on pharmaceutical science, laws and regulations

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

early. Learning Objectives:  Under the guidance of the mentors, you will have the following learning outcomes; Learn the FDA database navigation system Learn how the biomarker assists the drug development

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

regulatory science and prepare the next generation of regulatory scientists. Learning Objectives: The fellowship combines structured learning with applied regulatory research. You will attend seminars

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

understanding of HLA-restricted T-cell activation. Learning Objectives: Under the guidance of a mentor, you will gain experience in and learn to: Identify Impurity-Derived Neoepitopes via Immunopeptidomics Define

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

analysis, web-scraping, and traditional statistical methods. This will transform OQS surveillance operations while providing educational opportunities for staff to learn about the regulatory landscape and

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

release from glycoprotein drugs with chemo-enzymatic methods and characterize glycan structures with state-of-the-art technologies, including H(U)PLC and mass spectrometry (MS). Learning Objectives: Under

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 8 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

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 8 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 8 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