Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation (formerly known Division of Scientific Investigations (DSI) at Center for Drug Evaluation and Research (CDER) in FDA.
FDA Perspective on International Clinical Trials
The number of clinical trials sites located at non-U.S. sites which contribute data in support of U.S. marketing applications for drug approval is increasing. Clinical trials in support of regulatory submissions to FDA must be conducted in accordance with FDA regulations to assure the safety, efficacy, and ethical development of medical products whether the clinical studies are conducted in the U.S or abroad. This presentation is designed to advance the understanding of the FDA’s perspectives on clinical trials conducted outside the U.S for U.S NDA/BLA submissions, with an emphasis on distribution of data in FDA submissions, and U.S. law governing foreign clinical trials. GCP validation of data obtained through onsite inspections to assure data quality, integrity, and ethical development of medical products will also be discussed.
Dr. Ayalew oversees verification of the integrity of efficacy and safety data submitted to the FDA in support of new drug and biologic applications and the protection and assurance of the rights and welfare of human research subjects.
Dr. Ayalew obtained his M.D. in 1989 from Haile Selassie University Medical Faculty in Addis Ababa, Ethiopia. Following graduation, he worked as an assistant professor in the Department of Pediatrics at the Gondar University of Medical Sciences in Ethiopia. After awarded a scholarship, he completed post-graduate training in pediatrics and child health at Leipzig University in Germany. Following successful completion of his post-graduate residency training at Leipzig University, he also completed pediatrics residency at the Long Island College of Medicine followed by a fellowship program at Children’s National Medical Center/ George Washington University in 2000. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is double board certified in Pediatrics and Infectious Disease by American Board of Pediatrics.
Dr. Ayalew serves as a pediatrician at Inova Fair Oaks Hospital in Virginia where he actively continues to provide clinical services in pediatrics and pediatric infectious diseases. He has given numerous didactic lectures and case presentations. He has published publications in peer review journals and holds several awards and credentials from FDA. He has over 27 years of clinical experience, and over 17 years of regulatory medicine and work experience in FDA.