CDER/FDA/OC/OSI/DCCE
Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. 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 received his M.D. 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. He completed postgraduate training in pediatrics and child health at Leipzig University in Germany and at the Long Island College of Hospital followed by a fellowship program at Children’s National Medical Center/ George Washington University where he also obtained an MPH in public health. Dr. Ayalew holds an active license to practice medicine in State of Virginia. He is board certified in Pediatrics and Infectious Disease.
Dr. Ayalew also works in Urgent Care in Virginia where he provides clinical services to both pediatrics and adult patients. He has given numerous didactic lectures, case presentations and published publications in peer review journals. He has decades of clinical and regulatory work experience.
Tuesday, November 19, 2024
1:45 PM – 3:00 PM PT
Wednesday, November 20, 2024
8:45 AM – 10:00 AM PT