Speakers

Karen Ireland is a Supervisory Regulatory Health Project Manager in OPQ’s Office of Program & Regulatory Operations (OPRO). Ms. Ireland has been in FDA with OPRO since 2017 and has experience supporting the quality review of abbreviated new drug applications (ANDAs). She currently supervises a staff of ten ANDA Regulatory Business Process Managers. Ms. Ireland has a Bachelor of Science in Microbiology from University of California, San Diego and a Master of Science in Biotechnology (concentration in biodefense) from Johns Hopkins University. She also is certified in project management and regulatory affairs (drugs).