A Primer on Clinical Research
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This presentation will introduce different practices and principles for how new medicals products are identified as safe and effective, and ultimately introduced into the marketplace. How clinical research came to be and how professionals deal with proving that products are safe and effective will be discussed. Lastly, the speaker will discuss the evolving research approaches used today.
LEARNING OBJECTIVES
Discuss how new medical products might help to identify and mitigate the impact of COVID-19, and other viruses, on our health
Discuss different practices and principles for how products are identified as safe and effective for humans
Discuss how new products are introduced into the marketplace
Pat Beers Block, MDEd, BS, BS, CCRP
Lecturer
As a lecturer for Rutgers University, School of Health Professions, Department of Health Informatics, Pat develops and presents courses for the School’s Master degree program in Clinical Trials (2010-present). From February 2010-12, Pat served as Vice President of Regulatory Policy within the Regulatory Compliance Team for Medidata Solutions Worldwide. In this capacity, Pat assisted Medidata in its understanding of local and international regulations related to GCP and electronic data capture. Prior to joining Medidata, Pat held increasingly more responsible positions during her 33 year career with the US Food and Drug Administration. Pat has been a regular contributor to programs developed by professional organizations including SOCRA and eClinical Forum. Pat received the Distinguished Career Service Award from FDA at her retirement and is a member of Phi Kappa Phi and Alpha Zetta honor societies. Pat is currently certified by SOCRA as a Clinical Research Professional (CCRP) and serves on the Board of Directors for SOCRA.