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X-WR-CALNAME:Prof. Bawazir Pharma Consulting Center
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DTSTART:20190101T000000
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DTSTART;TZID=Europe/Moscow:20201229T090000
DTEND;TZID=Europe/Moscow:20201230T170000
DTSTAMP:20260425T151940
CREATED:20201124T111929Z
LAST-MODIFIED:20201223T140200Z
UID:3720-1609232400-1609347600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained-29-30 December\,2020- Riyadh
DESCRIPTION:FEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE PAY YOUR FEE BEFORE 28th December\, 2020.\nSAR 3500.00\n\n\n\nOVERVIEW \n  \nUnderstanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields\, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research\, data management\, basic research\, and marketing\, etc. \nDownload PV Brochure Riyadh 29-30 December 2020 \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance\n\n  \n 
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-22-23-december2020-riyadh/
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