Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012

  • 09 May 2012
  • Webinar

Description

Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012 is a webinar that covers topics such as:

  • General information regarding GCP and clinical studies
  • The applicable statutes and FDA regulations for clinical trials
  • Requirements for INDs and IDEs
  • The roles of clinical investigators, institutional review boards, sponsors, monitors and contract research organizations
  • ISO 14155
  • ICH-GCP guidelines
  • Strategy "CAC-SI" method
  • FDA enforcement actions

Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012 brings together:

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)
  • Quality Engineers, Managers,Directors, and VPs
  • R&D Scientists, Engineers, Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Compliance Officers and Legal Counsel
  • Consultants
  • Clinical investigators and CRO employees
  • Senior and Executive Management Anyone involved in the clinical trials or studies

Past Events

Important

Please, check "Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical laboratories, Pharma
Science: Laboratories, Life Sciences & Biology

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