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Webinar On - Good Documentation Practices for Clinical Trials

Online Webinar

Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices.  To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.  The documentation requirements including a set of SOPs with key elements to be contained in the SOP will be discussed.  In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety. Areas Covered in the Session: Statutes, Regulations and DefinitionsRegulatory Requirements for INDs and IDEs.Clinical TrialsClinical Investigators (CI)Institutional Review Boards (IRBs)Sponsors and MonitorsContract Research Organizations (CROs)ICH-GCP GuidelinesISO 14155List of SOPs and Adequate DocumentationKey Elements in the SOPsCommon GCP Deficiencies in EU and USEnforcement ActionsLessons Learned Who Will Benefit: Clinical AffairsRegulatory AffairsQuality AssuranceR&DConsultantsContractors/SubcontractorsSenior ManagementAnyone Interested in the Topic


4 Feb 2014 @ 12:00 am

4 Feb 2014 @ 12:00 am

Duration: 0 hours

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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