Sponsor’s Role in Regulatory Testing — Complying with GLP Standards

Hosted by Bergeson & Campbell, P.C.

Location, or Event type: Bergeson & Campbell Webinar

Sponsor’s Role in Regulatory Testing — Complying with GLP Standards

Webinar, Hosted By Bergeson & Campbell, P.C.


Wednesday, June 12, 2024 - 11:00 AM - Wednesday, June 12, 2024 - 12:00 PM


Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practice (GLP) regulations and related advisory documents, to ensure that non-clinical health and environmental safety studies are conducted in compliance with GLP. This webinar will focus on the GLP requirements that are specifically or implicitly assigned to Study Sponsors and will provide an overview of activities and considerations within this role that are critical to the development of compliant data. The presenters will additionally highlight similarities and differences between U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and Organisation for Economic Co-operation and Development (OECD) GLP regulations as they relate to Study Sponsors’ roles and responsibilities in GLP-compliant testing to support global regulatory objectives.

Topics Covered:

  • Background of GLP Standards — What is the benefit of GLP compliance? 
  • GLP requirements for Sponsors — Where does the Sponsor fit into GLP?
  • Critical Sponsor activities — Do’s and Don’ts during study conduct.
  • Key considerations for ensuring compliance and assuring data quality enforcement risks and effects of non-compliance — Are your studies inspection ready?
 

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