11 Design Fellowship positions at Center for Drug Evaluation and Research (CDER) in Ireland-United-Kingdom in United States

FDA Bioequivalence of Complex Generic Products Fellowship

products with device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in

Clinical Pharmacology of Therapeutic Biologics and Biosimilars Fellowship

depends on the characteristics of PK (and PD when appropriate). Given the diversity of therapeutic proteins in structural features and in the PK properties, the study design characteristics for the PK

FDA-CDER Fellowship in the Intranasal Administration of Monoclonal Antibodies and other Biological Therapeutics

thinking, experimental design and aseptic technique and gain specialized skills including cell culture, immunohistochemistry, real-time PCR, and western blotting. Additionally, the participant will have

FDA In Vitro and In Vivo Bioequivalence Fellowship

polymer-based drugs, oral inhaled and nasal products, topical and transdermal drugs, and combination drug-device products with device components that may themselves have degrees of complexity in design. In

FDA Fellowship in Biomarker Use in Rare Disease Drug Development

an important element in making a regulatory decision in rare diseases where natural history, size and length of development program, and trial design were challenging. This data review will focus on prior uses

Anti-infective Fellowship: Pediatric Clinical Pharmacology

the development of anti-infective drugs for pediatric use. Specifically, the results of the project are expected to provide best practices for designing and evaluating pediatric drug development programs, and to

FDA Epidemiology to Enhance Safety Surveillance Fellowship

products and associated adverse events. Learning Objectives: Under the guidance of the mentor, the participant will increase understanding of the design and methods of the National Survey on Drug Use and

FDA Pharmacovigilance Fellowship: Methodological Assessment of Causal Associations

, interpret, and assimilate pharmacoepidemiologic literature to frame, design, and inform research questions. 2. Develop transferable skills in conducting methodological assessments that may be expanded

FDA Research Fellowship in Large Language Models for Clinical Pharmacology

language models (LLMs) for internal use, collaborate to design, develop, and refine large language models and generative models for various applications. Under the guidance of the mentor, the participant

FDA Fellowship in Program, Policy and Operational Analysis

, designs and implements new programs, advances structured benefit-risk assessment in regulatory decision making and evaluates key business processes using evidence-based approaches that assess the value