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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from March 2023
The development of medicinal products and medical devices is built upon the foundation of benefit-risk assessment. The process begins – and ends – with identifying, understanding, analyzing, and mitigating an investigation product’s risk.
Risk Management Principles for Devices and Pharmaceuticals, third edition, aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices. It provides readers with up-to-date information to help them minimize harm and maximize the efficacy of the products and devices they seek to bring to market.
This updated book contains all the practical information of its predecessor, including preclinical, clinical, and post-marketing risk evaluation; regional risk management requirements; benefit-risk assessment; pregnancy registry use; and quality risk management. The content is augmented by in-depth case studies that will provide readers with a concrete understanding of how to be a strategic member of their organizations’ risk management teams.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
This book was developed for regulatory professionals of all levels of RAPS’ Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and governmental employees. Professionals at levels 1 and 2 of the framework will find in one convenient place relevant regulations and guidance in specific countries and how to apply them. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on regulations and policy worldwide.
J. Michael SprafkaPrincipal, Woodford Research Associates
J. Michael Sprafka, PhD, MPH, is a principal at Woodford Research Associates, LLC. Sprafka has more than 25 years of experience in regulatory affairs specializing in pharmacovigilance, outcomes research, pharmacoeconomics, and epidemiology. Previously, Sprafka was executive director of bone, inflammation, and nephrology at Amgen’s Center for Observational Research, where he was responsible for the design and conduct of epidemiological research for molecules in development and the marketplace for these therapeutic areas. He also served as vice president for consulting at Kendle International, a clinical research organization, and spent 15 years with Procter & Gamble Pharmaceuticals. Sprafka is a graduate of the University of Minnesota with a bachelor’s in biology, master’s in environmental health, and MPH and PhD in epidemiology. Previously, he worked at the University of Minnesota School of Public Health as director of graduate studies in the division of epidemiology, where he conducted research in cardiovascular disease, diabetes, and cancer. He has authored more than 150 manuscripts, reports, and book chapters. He serves on RAPS’ Editorial Advisory Committee.
Elaine MorratoFounding Dean and Professor, Parkinson School of Health Sciences and Public Health, Loyola University Chicago
Elaine H. Morrato, DrPH MPH CPH is professor and founding dean for the Parkinson School of Health Sciences and Public Health, Loyola University Chicago. Trained in epidemiology and board-certified in public health, her work focuses on accelerating the translation of evidence into practice with a particular focus on drug safety. Morrato’s global pharmaceutical industry experience at Procter and Gamble developing and commercializing new drugs and indications informs her implementation science research and practice. She remains active in the NIH Clinical & Translational Sciences Award program, where she directs Loyola’s collaboration with the University of Chicago-Rush University Institute for Translational Medicine. She is a mentor in the national expansion of the Innovation-Corps training program for ensuring problem-solution fit and the scale-up and sustainability of academic innovation. She regularly advises the FDA on issues of pharmaceutical risk communication and management and completed a visiting professorship with the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research.
Bruce DeMarkRetired Research Fellow, Procter & Gamble Pharmaceuticals
Bruce DeMark retired from Procter & Gamble Pharmaceuticals in 2011. He spent the last 18 years of his career as a regulatory affairs scientist. His major responsibility was providing regulatory leadership in cross-functional, drug-development, global project teams. In this role he led all FDA pre-submission and post-submission activities related to the development of new and supplemental drug applications and provided technical support for Canadian NDS and European MAA submissions. A major focus of his was Actonel—initially approved for the treatment of Paget’s Disease—that won approval for the treatment and prevention of post-menopausal, corticosteroid-induced, and male osteoporosis in daily, weekly, and monthly dosing regimens.
DeMark received his Ph.D. in biochemistry from the University of Southern California. Following a two-year post-doctoral appointment at Argonne National Laboratory Bioanalytical Center, he joined Procter & Gamble to manage a Bioanalytical Laboratory for pharmaceutical products.
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