Theresa Shalaby is Senior Regulatory Services Manager and Plain Language Summary Functional lead at Certara. Theresa has 30 years of experience in the clinical research and drug development industry and has extensive clinical writing experience. She has an MSN and Clinical Research Management from Vanderbilt University. She has expertise in the therapeutic areas of pediatrics, neonatology, pediatric cancer, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, vascular diseases, critical care, and rare diseases. Theresa has also written Informed Consent Forms (ICFs) in the therapeutic areas of pediatric gastroenterology, cancer, hematology, and pulmonary and respiratory diseases, and has experience in presenting ICFs and educational materials to patients and families.