Regulatory Science Series

This Career Development Seminar Series dedicated to Regulatory Science (6 two-hour sessions) brings together experts across USC that integrate key regulatory science knowledge and skills for conducting clinical translational research with the goal of accelerating health related discovery to the public.

Although we all have heard about regulatory science, many of us still are not aware of what it really is or why it is so closely aligned with successful clinical translational research. During these six sessions the USC experts intend to discuss important components of this science that FDA defines as “the science that develops new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA regulated products”.

Frances Richmond - Risk Assessment and Management Tools - Part 1

Frances Richmond, PhD
Professor and Director, Regulatory Science Program
Clinical Pharmacy and Pharmaceutical Economics and Policy

In this second session, Dr. Frances Richmond introduces us to the concepts of Risk Assessment and Management Tools as formal processes within the Regulatory framework we should all be aware of as clinical translational researchers who work with FDA approved drug or devices. Interestingly, she comments that these important regulatory strategies are “not particularly written in textbooks and fall in the cracks”.

During Part 1 and 2 of this session we learn about:

1. The definition of risk and a historical perspective of risk assessment and management
2. Key players involved in evaluating risk
3. Types of risk
4. Risk Management Standards and Processes
5. Examples of Risk Assessment and Management Tools

Resources:
1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry Q9 Quality Risk Management. June 2006. Available at: fda.gov/downloads/Drugs/.../Guidances/ucm073511.pdf
2. International Organization for Standardization (IS0) 14971. Medical devices-Application of risk management to medical devices. Available at: osmundacn.com/asp_bin/downfile/20070718164118757_68.pdf
3. FDA Medical Device Industry Coalition. ISO 14971: Overview of the Standard. Risk Management through product life cycle: An educational forum. Available at: fmdic.org/wp-content/uploads/2010/12/overview-risk.pdf
4. Walker S et al. Developing a common benefit-risk assessment methodology for medicines – a progress report. Available at: cirsci.org/system/files/private/SRA_Dec%202011_Developing_Walker_McAuslane_Liberti%5B1%5D.pdf

SC CTSI - Education and Career Development Seminar Series:
Facilitator: Cecilia M. Patino-Sutton, MD, PhD, Director of Education, SC CTSI ECDE, Department of Preventive Medicine
Media Technology: Gary San Angel, Distance Education Specialist, Department of Preventive Medicine

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