36 evolution-"https:"-"https:"-"https:"-"Linnaeus-University" research jobs at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 15 days ago

., drug safety, substance use disorders, pharmacovigilance, pharmacoepidemiology methods development). Through this fellowship, you will have opportunities to learn: Understanding of pharmacovigilance

FDA Fellowship - Elsa API integration and Development of Advanced User Interface for InfoViP

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 15 days ago

, pharmacoepidemiology methods development). You will have learning opportunities that include: Understanding of pharmacovigilance data analysis workflows; Full-stack web-based application development; Integration

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland. The Center for Drug Evaluation and Research...

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 | 15 days ago

disorders, pharmacovigilance, pharmacoepidemiology methods development). Mentor: The mentor for this opportunity is Jason Flint, MBA, PMP, (Jason.Flint@fda.hhs.gov ). If you have questions about the nature

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

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

challenge to pediatric drug development especially for the younger children. Some of the challenges in using pediatric drug-device combination products include the delivery of inadequate doses for achieving

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 | 15 days ago

(PROs) represent the only quantitative tool available to assess tolerability of oncologic agents under development, providing unique insights into the patient experience of symptomatic adverse events

FDA Product Specific Guidance and Research Fellowship

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

from FDA-funded scientific research can be used to support PSG development. This project includes the development of knowledge management and research management tools to maintain, monitor, and analyze

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

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

developing comprehensive databases to systematically evaluate the current landscape of in vitro data utilization in drug development. This research will contribute to the development of innovative

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

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

to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 15 days ago

will contribute to developing internal FDA guidance and supporting peer-reviewed publications on appropriate non-inferiority study design and margin justification in modern ophthalmic drug development