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Webinar On Good Documentation Practices for Clinical Trials

Documentation requirements during clinical trials for both drugs and medical devices

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 LearnedWho Will Benefit:Clinical AffairsRegulatory AffairsQuality AssuranceResearch & DevelopmentConsultantsContractors/SubcontractorsSenior ManagementAnyone Interested in the TopicPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

20 Feb 2015 @ 01:00 pm

20 Feb 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Organised by

Compliance Trainings (deactivated)

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