Events

Events November 8, 2019: Vaccines and Related Biological Products Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss and make recommendations on the development of chikungunya vaccines. November 12-14, 2019: Regulatory Education for Industry (REdI): Clinical Investigator Training Course (College Park, MD) This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products. November 18, 2019: Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making Public Workshop (Silver Spring, MD and webcast) - To discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. Register by November 8, 2019. November 18-19, 2019: Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development (Silver Spring, MD and webcast) - Co-sponsored by FDA, the Infectious Diseases Society of America (IDSA), the National Institute of Allergy and Infectious Diseases (NIAID), and Pew, this workshop will bring together a diverse array of subject matter experts in the fields of infectious diseases (ID), academics and industry and other government bodies to better understand the current state of U.S.-based ID trials and how to enhance enrollment and research in such trials. Register by November 14, 2019. November 18-21, 2019: Chemical and Biological Defense Science & Technology (CBD S&T) Conference (Cincinnati, OH) - Hosted by the Defense Threat Reduction Agency (DTRA). FDA will be presenting as part of a panel on Alternate and Innovative Mechanisms to Conduct Medical Countermeasure Discovery and Development with the Federal Government. Register by November 1, 2019. November 22, 2019: Blood Products Advisory Committee meeting (Silver Spring, MD and webcast) - The committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.