In this presentation the speaker 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 presented. Lastly, the speaker will discuss the evolving research approaches used today.
This is a 50 minute internet media player video of a voice over slide show.
A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.
At the completion of the webinar, participants should be able to:
Speaker:
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.
Members - Free
Non-Members - $75.00 (includes 1 year membership)
If you are not a current member, you will be asked to create an account to view the online training.
SOCRA designates this educational activity for a maximum of 1.0 Continuing Education Credits for SOCRA CE and Nurse CNE. SoCRA designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Termination Date: 4/1/2026