Understanding regulatory requirements in regions throughout the world is critical for ensuring the proper conduct and analysis of pharmaceutical clinical research. This webinar program will focus on the regulatory requirements of the U.S.A. ( FDA) and Europe (EMA) with particular emphasis on regional good clinical practice requirements and guidances that have an impact on clinical data managers. Coverage of FDA regulations and EMA directives, and ICH publications will be examined. Additionally, regulatory requirements for other important regions such as Asia Pacific and south-Latin Americas which are currently engaged in clinical research will be introduced.
What You’ll Learn
• You will learn about important regulatory principles that are practiced and expected in different regional areas where clinical research is being conducted.
• You will learn about important guidances and best practices that are recommended by various regional government agencies
• You will be able to find relevant information that is publically available through internet connections after the completion of this webinar.
Who Should Attend
Beginning to intermediate level site staff, CDMs, and quality assurance/control staff
This webinar will introduce basic regulatory requirements about which attendees should be well versed.
Pat Beers Block
Pat works part time as an Adjunct Assistant Professor for Rutgers/UMDNJ University, School of Health Professions, Department of Health Informatics, developing and presenting courses for the School’s Masters 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 at 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 U.S. Food and Drug Administration. During her tenure with FDA, Pat acquired extensive knowledge of the regulations, policies, inspectional program, and regulatory review process governing investigational drugs. Her positions ranged from field Investigator, Supervisory Investigator, Compliance Officer within CDER Office of Compliance, Approvals and Review Manager within CDER’s Office of Generic Drugs, and Expert Consumer Safety Officer within the Office of the Commissioner. Highlights of Pat’s FDA career include serving as the Part 11 co-chair from 2009-2010; coordinating the development and publication of FDA’s guidances entitled “Computerized Systems Used in Clinical Investigations”, and the “Statement of the Investigator (FDA Form 1572)”; and developing and presenting training programs to various regulatory authorities throughout the world. Pat has been a regular contributor to programs developed by professional organizations including SCDM, DIA, and SoCRA. Ms. Beers Block graduated with honors from Rutgers University with a BS in Biological Sciences, and from the University of Maryland University College with a BS in Computer and Information Science, and has taken several graduate level course in Computer Science at the Johns Hopkins University. Pat received the Distinguished Service Award from FDA at her retirement. She is currently certified by SoCRA as a Clinical Research Professional (CCRP).
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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