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X-WR-CALNAME:Prof. Bawazir Pharma Consulting Center
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X-WR-CALDESC:Events for Prof. Bawazir Pharma Consulting Center
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DTSTART:20210101T000000
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DTSTART;TZID=Europe/Moscow:20221025T090000
DTEND;TZID=Europe/Moscow:20221025T163000
DTSTAMP:20260425T065438
CREATED:20220806T224748Z
LAST-MODIFIED:20221002T122848Z
UID:5226-1666688400-1666715400@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 25 October\, 2022 Riyadh
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 23 October\, 2022. \n\nSAR 1500.00\n\n\n\n\nOVERVIEW \nThis course will offer insight into the compilation of the  eCTDs\, share experience and best practices gained during eCTD  submissions in the GCC\, explain the eCTD review and lifecycle process and the upcoming eCTD requirements. \n  \nDownload Brochure Common Technical Documents (CTD) and (eCTD) preparation 25_October_2022 Riyadh\, Saudi Arabia \n  \nLEARNING OBJECTIVES \nEvery regulatory professional should have a solid understanding of the standards\,  groundwork\, expertise and technology required to submit compliant eCTD  submissions. This begins with understanding what will be accepted and what will  not. Put yourself and your company a step ahead of competitors by understanding  the technical skills and regulatory requirements necessary to meet the impending  eCTD mandates. \n  \nAt the conclusion of this course\, participants will be able to: \n\nParticipate in the preparation of the eCTD including “submission ready documents”\nRecognize eCTD requirements on a regional and ICH basis\nCreate and submit technically valid GCC eCTDs\nPrepare to move from a paper to eCTD process\nDescribe technology used for eCTD compilation\, validation and review\nUnderstand the difference between eCTD and NeeS submission\nHave an overview on future eSubmission development\n\n  \nKEY TOPICS \n\nOverview of eCTD readiness at the agencies\nImpact of the eCTD on regulatory processes and procedures\nPractical experience of submitting an eCTD in the GCC\neCTD compilation and life cycle management\neCTD Validation\nDocument granularity and readiness\nTechnical issues\nSpecifications and standards\n\nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nScientific Office Managers\nRegulatory Authorities.\nDossier Management\nPharmacist\nCompliance\nSubmission Management/Electronic Publishing\nData Management / IT
URL:https://bawazirpharma.com/event/common-technical-documents-ctd-and-ectd-preparation-25-october-2022-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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