75 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "https:" "Mines Paris PSL" positions at Center for Drug Evaluation and Research (CDER) in United States

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

substitutability evaluation. Learning Objectives: Under the guidance of the mentor, you will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 15 hours ago

to identify where to direct surveillance efforts. Learning Objectives: Under the guidance of the mentor, you will gain knowledge on the development of an analytical method based upon multiple standards

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

Center for Drug Evaluation and Research (CDER) | United States | 28 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 Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 16 hours ago

(DP) plans to re-evaluate these rare safety signals and to determine whether additional regulatory actions are needed. Learning Objectives: Under the guidance of a mentor, you will have the following

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 15 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 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 | about 16 hours 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 | 28 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 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 16 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 | about 16 hours 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 Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 16 hours 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