UC-MEXICO REGULATORY SCIENCE, DRUG DEVELOPMENT AND PUBLIC HEALTH ONLINE COURSE
COURSE DESCRIPTION
Regulatory science concerns "the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality". With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century's evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. This basic and introductory course in regulatory science sponsored by the UC-Mexico Initiative, addresses the demand for increased training in the US and Mexico by providing an overview of the basic elements of regulation of health practice and health products.
The aim of the Regulatory Science, Drug Development and Public Health Online Course is to provide students with information needed to understand the most important health practice and product regulation issues in México and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for US and Mexico as well as regional context.
The faculty for the course are leading experts in various areas that are affected by regulation from binational institutions including the University of California at Berkeley, the National Autonomous University of México (UNAM by its Spanish acronym), the National Institute of Public Health (INSP), and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Regulatory agency and Biotech and pharmaceutical industry experts participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health communities.
The course is of interest to participants in regulatory agencies, public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry, working in the settings of industry or regulatory agencies. As the biomedical industry continues to rapidly grow, the demand for professionals in the regulatory sciences does so as well, nationally, bi-nationally and globally. The course is also offered as a component of the UC Berkeley Online MPH program.
INSTRUCTOR INFORMATION
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, a public and private partnership addressing cutting edge science and policy issues through a process of stakeholder engagement and deliberation. Dr. Miller is also Professor (Adjunct) at the UC Berkeley School of Public Health. She developed and teaches a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
COURSE OBJECTIVES/GENERAL COMPETENCIES
By the end of the course, participants will be expected to be able to:
• Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
• Identify, asses, think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
• Explain and critically evaluate the clinical research process and asses the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
• Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
COURSE DESCRIPTION
Regulatory science concerns "the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality". With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century's evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. This basic and introductory course in regulatory science sponsored by the UC-Mexico Initiative, addresses the demand for increased training in the US and Mexico by providing an overview of the basic elements of regulation of health practice and health products.
The aim of the Regulatory Science, Drug Development and Public Health Online Course is to provide students with information needed to understand the most important health practice and product regulation issues in México and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for US and Mexico as well as regional context.
The faculty for the course are leading experts in various areas that are affected by regulation from binational institutions including the University of California at Berkeley, the National Autonomous University of México (UNAM by its Spanish acronym), the National Institute of Public Health (INSP), and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Regulatory agency and Biotech and pharmaceutical industry experts participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health communities.
The course is of interest to participants in regulatory agencies, public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry, working in the settings of industry or regulatory agencies. As the biomedical industry continues to rapidly grow, the demand for professionals in the regulatory sciences does so as well, nationally, bi-nationally and globally. The course is also offered as a component of the UC Berkeley Online MPH program.
INSTRUCTOR INFORMATION
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, a public and private partnership addressing cutting edge science and policy issues through a process of stakeholder engagement and deliberation. Dr. Miller is also Professor (Adjunct) at the UC Berkeley School of Public Health. She developed and teaches a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
COURSE OBJECTIVES/GENERAL COMPETENCIES
By the end of the course, participants will be expected to be able to:
• Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
• Identify, asses, think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
• Explain and critically evaluate the clinical research process and asses the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
• Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
