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

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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 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 12 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 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 | 1 day 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 Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

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

communicated in FDA-approved product labeling, comparing review findings with final labeling language to identify alignment patterns and improvement opportunities. Learning Objectives: Your educational training

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 Product Specific Guidance and Research Fellowship

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

how the impact of outcomes from a scientific research program can be maximized to support future decision making. Learning Objectives: You will gain insight into the FDA's Office of Generic Drugs, and

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

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

or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between

FDA Over the Counter Drug Monograph Research Fellowship

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

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Clinical Research Fellowship

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

on how co-use should be evaluated for impairment. Learning Objectives: The fellowship will provide structured learning opportunities in clinical pharmacology, pharmacokinetics, regulatory science

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

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