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

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days 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 Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 2 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 Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days 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 | 2 days 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 Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days 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 Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

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

for bioequivalence assessment. Learning Objectives: Upon completion of the fellowship, you will have learned; Proficiency in evaluating whether Dunnett’s procedure is applicable to equivalence test setting. Advanced

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

. Learning Objectives: Under the guidance of the mentor, you will participate in specialized training programs covering regulatory science principles and FDA's review processes for novel biological products

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

. Learning Objectives: Under the guidance of the mentor(s), you will be involved in the following activities: (1) perform a literature search related to the background of the project, (2) create a database