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DTSTART:19700308T020000
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UID:2140535:Event:63019
DTSTAMP:20260521T061221Z
SUMMARY:Webinar On - Good Documentation Practices for Clinical Trials
DESCRIPTION:This webinar is intended to help you adequately implement 
 Good Clinical Practices (GCP): in particular, documentation requiremen
 ts during clinical trials for both drugs and medical devices. \n \nT
 o adequately implement GCPs, there are a set of standard operating pro
 cedures (SOPs) to be established and maintained at any given facility,
  to the extent applicable, as a sponsor, clinical investigators, monit
 ors, and CROs, etc. \n \nThe documentation requirements including a 
 set of SOPs with key elements to be contained in the SOP will be discu
 ssed. \n \nIn this 60-min webinar, you will have unparalleled opport
 unities to bring great value and benefits to your organization and to 
 greatly improve your GCPs with increased awareness of the needs - sust
 ainable compliance and patient safety.\n \nAreas Covered in the Sessi
 on:\n\nStatutes, Regulations and Definitions\nRegulatory Requirements 
 for INDs and IDEs.\nClinical Trials\nClinical Investigators (CI)\nInst
 itutional Review Boards (IRBs)\nSponsors and Monitors\nContract Resear
 ch Organizations (CROs)\nICH-GCP Guidelines\nISO 14155\nList of SOPs a
 nd Adequate Documentation\nKey Elements in the SOPs\nCommon GCP Defici
 encies in EU and US\nEnforcement Actions\nLessons Learned\n\n \nWho W
 ill Benefit:\n\nClinical Affairs\nRegulatory Affairs\nQuality Assuranc
 e\nR&D\nConsultants\nContractors/Subcontractors\nSenior Management\nAn
 yone Interested in the Topic\n\n\nFor more information visit https://m
 edtechiq.ning.com/events/webinar-on-good-documentation-practices-for-c
 linical-trials
DTSTART;TZID=America/New_York:20140204T120000
DTEND;TZID=America/New_York:20140204T130000
CATEGORIES:online, training
LOCATION:Online
WEBSITE:https://www.compliancetrainings.com
URL:https://www.compliancetrainings.com
CONTACT:Suzzane Dmello
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011031?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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