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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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TZID:Europe/Moscow
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DTSTART:20190101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20210222T090000
DTEND;TZID=Europe/Moscow:20210222T173000
DTSTAMP:20260425T183257
CREATED:20210125T140113Z
LAST-MODIFIED:20210323T143012Z
UID:3839-1613984400-1614015000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 22 February\, 2021 Riyadh
DESCRIPTION:  \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  21 February 2021.\nSAR 1000.00\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  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  \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  regulatory strategy\nDescribe key differences between National and the Gulf Cooperation Council Drug Registration (GCC_DR) regulatory requirements.\nDescribe the requirements for marketing applications for drugs and biologics\, New Drug Application (NDA)\, Biosimilares\, Generic drugs\, herbal and health products and document preparation.\nRecognise SFDA oversight and processes during the post-approval phase.\nInteract appropriately with the SFDA during all phases of drug registration\nUnderstand the regulatory requirements for prescription drug labelling and advertising/promotion.\n\n  \nKEY TOPICS \n\nPrincipals of Regulatory Affairs (RA) and Legal Framework\nSFDA overview and pharmaceutical institutions licensing\nPrinciples of Products licensing and Evaluation\nGMP Inspection and Products Pricing\nOverview of the pharmacovigilance system\nPrinciples of Products Classifications and Listing\nProducts Import\, Release and Advertising\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\n\n 
URL:https://bawazirpharma.com/event/basics-of-drug-regulatory-affairs-sfda-system-explained-training-22-february-2021/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20210215T090000
DTEND;TZID=Europe/Moscow:20210216T173000
DTSTAMP:20260425T183257
CREATED:20210125T125016Z
LAST-MODIFIED:20210323T135435Z
UID:3827-1613379600-1613496600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 15-16 February\, 2021 Riyadh
DESCRIPTION:  \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 10th February \, 2021.\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. \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\n\n  \n 
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-15-16-february2021-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20201229T090000
DTEND;TZID=Europe/Moscow:20201230T170000
DTSTAMP:20260425T183257
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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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20201222T090000
DTEND;TZID=Europe/Moscow:20201222T173000
DTSTAMP:20260425T183257
CREATED:20201124T112609Z
LAST-MODIFIED:20201126T122606Z
UID:3723-1608627600-1608658200@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs - SFDA System Explained Training 22/12/2020
DESCRIPTION:FEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE PAY YOUR FEE BEFORE                      17th December\, 2020. \nSAR 1000.00\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  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. \nDownload Basics of Drug Regulatory Affairs Brochure 22 December 2020 \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  regulatory strategy\nDescribe key differences between National and the Gulf Cooperation Council Drug Registration (GCC_DR) regulatory requirements.\nDescribe the requirements for marketing applications for drugs and biologics\, New Drug Application (NDA)\, Biosimilares\, Generic drugs\, herbal and health products and document preparation.\nRecognise SFDA oversight and processes during the post-approval phase.\nInteract appropriately with the SFDA during all phases of drug registration\nUnderstand the regulatory requirements for prescription drug labelling and advertising/promotion.\n\n  \nKEY TOPICS \n\nPrincipals of Regulatory Affairs (RA) and Legal Framework\nSFDA overview and pharmaceutical institutions licensing\nPrinciples of Products licensing and Evaluation\nGMP Inspection and Products Pricing\nOverview of the pharmacovigilance system\nPrinciples of Products Classifications and Listing\nProducts Import\, Release and Advertising\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\n\n\n\n\n09:00 – 10:30 SESSION 1 \nPrincipals of Regulatory Affairs (RA) and Legal \nFramework \n\nThe history and evolution of the regulatory authorities\n\nand profession. \n\nPrinciples of Regulatory Affairs and regulatory professional\nBasic terms and definitions.\nLegal Framework for Pharmaceuticals regulations.\nSFDA Law.\nPharmaceuticals Institutions and Preparations Law.\nPrinciples of pharmaceutical preparations registrations.\nInternational Council for Harmonization (ICH) guidelines.\nNarcotics and psychotropic law.\n\n\n\n\n10:30 – 11:00: COFFEE BREAK \n11:00 – 12:30 SESSION 2 \nPrinciples of Products licensing and Evaluation \n\nABC for pharmaceutical products licensing.\nRegulatory Framework for Drug Approvals V_5 0.\nGuidance for Submission V_4 0.\nGeneral requirements for pharmaceuticals preparations registration.\nPrinciples of pharmaceutical preparations registrations.\nCommon Technical Document (CTD) and eCTD.\nPharmaceutical preparations evaluation process.\nRegistration Committees.\nProduct Variations Guidance.\n\n\n\n\n12:30 – 13:30 LUNCH \n13:30 – 15:00 SESSION 3 \nPrinciples of Products Classifications and Listing \n\nOverview of product classifications.\nGuidance for products classifications.\nPrinciples of products listing.\nOverview of the SFDA Electronic systems.\n\n \n\n\n\n 
URL:https://bawazirpharma.com/event/basics-of-drug-regulatory-affairs-sfda-system-explained-training-21-12-2020/
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