Post-Authorization Safety Studies of Medicinal Products. The PASS Book

Table of Contents

1. Introduction 2. Risk Management Process 3. Data Sources for PASS 4. Study Designs for PASS 5. Analytical Approaches for PASS 6. Benefit-Risk Evaluation 7. Other PASS 8. EU PAS Register

Authors

Ayad K. Ali Senior Pharmacoepidemiologist, Global Patient Safety, Eli Lilly and Company, IN, USA. Dr. Ali is a senior pharmacoepidemiologist at Eli Lilly. He is a Fulbright Scholar and has received many awards from professional and educational organizations, including complimentary memberships, travelships, and research and publication grants. He presented many of his research in pharmacovigilance and drug safety in national and international venues, and published in peer-reviewed journals. Additionally, he received memberships by election to the American College of Epidemiology and Sigma Xi the Scientific Research Society. He is a pharmacist by training and combines extensive experience in pharmacy practice in community, industrial, and academic settings, especially in pharmacoepidemiologic research and pharmacovigilance applications. Abraham G. Hartzema Professor and Eminent Scholar, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA. Dr. Hartzema is an eminent scholar and professor at College of Pharmacy, University of Florida, he served as the academic advisor to Dr. Ali and has extensive experience in pharmacoepidemiology and drug risk management. He is the editor of several books in the area of pharmacoepidemiology, and published numerous research and expert opinion articles in peer-reviewed journals. He also served as the lead scientist for the active surveillance sentinel initiative by the Food and Drug Administration. He also appears in several editions of Who's Who volumes.