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X-ORIGINAL-URL:https://bawazirpharma.com
X-WR-CALDESC:Events for Prof. Bawazir Pharma Consulting Center
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TZID:Europe/Moscow
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DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230201T090000
DTEND;TZID=Europe/Moscow:20230201T163000
DTSTAMP:20260428T183238
CREATED:20221129T100728Z
LAST-MODIFIED:20221129T100728Z
UID:5591-1675242000-1675269000@bawazirpharma.com
SUMMARY:Health and Herbal Products Development Process and Regulatory Approval 1 February 2023 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 \n\nSAR 1500.00\n\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 31 January 2023.\n\nSAR 1000.00\n\n\n\n\nOVERVIEW\nUnderstanding drug regulatory affairs in the GCC region is  very important for persons working in pharmaceutical  sector in the region. This course is specifically designed for  persons working in the regulatory affairs departments or  related fields\, who need knowledge of the SFDA and GCC  regulatory processes. This training will also enhance  understanding and be beneficial to persons who work in  clinical research\, data management\, basic research\,  project management and marketing\, etc. \n  \nDownload Brochure Health and Herbal Products Development Process\, and Regulatory Approval 1 February 2023\, Riyadh\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.\nDefine official regulatory policies and other issues pertinent to a successful SFDA and GCC regulatory strategy\nDescribe the requirements for marketing applications for\n\nherbal and health products and document preparation. \n\nRecognize SFDA oversight and processes during the post- approval phase.\nInteract appropriately with the SFDA during all phases of drug registration\n\n  \nKEY TOPICS \n\nPrincipals of Regulatory Affairs (RA) and Legal Framework\nPrinciples of Products licensing and Evaluation\nData requirements for health and herbal products\nOverview of the SFDA Electronic systems\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nFresh Graduate\nScientific Office Managers\nRegulatory Authorities.\nDossier Management\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/health-and-herbal-products-development-process-and-regulatory-approval-1-february-2023-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230206T090000
DTEND;TZID=Europe/Moscow:20230207T163000
DTSTAMP:20260428T183238
CREATED:20230112T120134Z
LAST-MODIFIED:20230112T120134Z
UID:5755-1675674000-1675787400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 6-7 February\, 2023 Jeddah\, Saudi Arabia
DESCRIPTION:Note:  This training require physical presence and will be held in Jeddah \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 5000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 3 February\, 2023.\nSAR 3500.00\n\n\n\nOVERVIEW \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. \n  \nDownload Brochure SFDA Pharmacovigilance System Explained 6-7_February 2023 Jeddah\, Saudi Arabia\n  \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\nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-6-7-february-2023-jeddah-saudi-arabia/
LOCATION:Will be confirmed few days before the training\, Jeddah
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230226T090000
DTEND;TZID=Europe/Moscow:20230227T163000
DTSTAMP:20260428T183238
CREATED:20230104T154451Z
LAST-MODIFIED:20230112T120809Z
UID:5721-1677402000-1677515400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 26-27 February\, 2023 Riyadh\, Saudi Arabia
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 5000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 19 February\, 2023.\nSAR 3500.00\n\n\n\nOVERVIEW \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. \n  \nDownload Brochure SFDA Pharmacovigilance System Explained 26-27 February 2023 Riyadh\, Saudi Arabia\n  \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
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-26-27-february-2023-riyadh-saudi-arabia/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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