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

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

will advance FDA's regulatory science mission and public health objectives while promoting the 3Rs principles (replacement, reduction, and refinement) of animal use during drug development. 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 8 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 Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

product testing requirements. Learning Objectives: Educational and Training Components: You will receive multidisciplinary training in: Regulatory science methods: Understanding how final formulation test

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

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

to integrate findings into regulatory science discussions. Learning Objectives: You will receive multidisciplinary training in: Regulatory science methods: Understanding how microbial risk assessment informs OTC

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours 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 Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

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

drug exposure and contribute to the FDA’s ongoing efforts to ensure the safety of medications used during lactation. Learning Objectives: Under the guidance of the mentor, you will receive structured

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 | 8 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 Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

optimization strategies in oncology clinical trials. Learning Objectives: As an ORISE fellow you will have the opportunity to: Investigate the application of validated PRO instruments into exposure-response

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

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

therapeutic classes. Learning Objectives: The fellowship integrates five key training areas: (1) FDA systems training in DARRTs and Docubridge navigation; (2) regulatory knowledge development through attendance