39 evolution "https:" "https:" "https:" "https:" "https:" "https:" "Newcastle University" research jobs at Center for Drug Evaluation and Research (CDER) in United States

FDA Pharmacy Compounding Regulatory Analysis Fellowship

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

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

for novel drug applications Gain understanding of data pipelines used for dashboard development. Mentor: The mentor for this opportunity is Mary Doi (mary.doi@fda.hhs.gov ). If you have questions about the

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

is applied to Individual Case Safety Reports (ICSRs). They will support the development and refinement of the AI prototype, providing a practical introduction to how AI can be applied to a regulatory

FDA Fellowship - Large language Models in Post-Market Surveillance of Drugs Using Social Media

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 12 days ago

to align your interests with areas of research need to OSE (e.g., drug safety, substance use disorders, pharmacovigilance, pharmacoepidemiology methods development). As an OSE-trained fellow, at

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

setting to conduct clinical trials; and (b) development of AI models for application to regulatory decision making, which is additionally valuable for opening up your future career opportunities. Mentor

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 12 days ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 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 - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | about 1 month 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

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

with multidisciplinary teams to curate large-scale datasets, investigating patterns in toxicological data using statistical methods, contributing to the development of reference compound libraries