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Recorded Webinar

Good Clinical Practice (GCP): FDA Regulations, Sponsors, Monitors, Clinical Investigators, CROs, and IRBs

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

This webinar is intended to provide a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, the requirements and compliance.

In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices including in vitro diagnostic devices are regulated by the Food and Drug Administration (FDA). Those (e.g., clinical investigators, sponsors, monitors, and CROs) conducting these clinical studies must comply with the applicable statutes and regulations, which covers good clinical practice (GCP). This webinar will discuss Good Clinical Practice (GCP) including the relevant and applicable FDA regulations. At the end of the Webinar, you will leave empowered with the applicable FDA regulations and requirements.

The presentation will cover the following areas:

  • Review of FDA regulations including INDs and IDEs
  • General information for clinical studies
  • Clinical investigators (CI)
  • Institutional review boards (IRBs)
  • Sponsors
  • Monitors
  • Contract research organizations (CROs)
  • ICH-GCP guidelines
  • ISO 14155
  • Enforcement actions


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