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X-ORIGINAL-URL:https://bawazirpharma.com
X-WR-CALDESC:Events for Prof. Bawazir Pharma Consulting Center
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BEGIN:VTIMEZONE
TZID:Europe/Moscow
BEGIN:STANDARD
TZOFFSETFROM:+0300
TZOFFSETTO:+0300
TZNAME:MSK
DTSTART:20210101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20221101T090000
DTEND;TZID=Europe/Moscow:20221101T163000
DTSTAMP:20260428T225035
CREATED:20220807T233400Z
LAST-MODIFIED:20221025T111921Z
UID:5271-1667293200-1667320200@bawazirpharma.com
SUMMARY:Basic of Good Manufacturing Practice (GMP) SFDA Explained 1 November\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  31 October\, 2022.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices\, regulatory affairs\, pharmaceutical manufacturers\, data management\, basic research\, project management and marketing\, etc. \n  \nDownload Brochure Basics of Good Manufacturing Practice (GMP) SFDA Explained 1_November_2022\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of SFDA GMP guidelines.\nDescribe the different types of GMP inspection.\nUnderstand The general GMP inspection components\n\n  \nKEY TOPICS \n\nGMP Legal Framework\nType of GMP Inspection\nQuality Management\nPersonnel\nPremises and Equipment\nDocumentation\nProduction\nQuality Control\nContract Manufacture and Analysis\nComplaints and Product Recall\nSelf Inspection\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nFresh Graduate\nScientific Office Managers\nRegulatory Authorities.\nPharmaceutical manufacturers\nPharmacist\nCRO staff\n\n  \n 
URL:https://bawazirpharma.com/event/basic-of-good-manufacturing-practice-gmp-sfda-explained-1-november-2022-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:20221102T090000
DTEND;TZID=Europe/Moscow:20221102T163000
DTSTAMP:20260428T225035
CREATED:20220808T135736Z
LAST-MODIFIED:20221025T112332Z
UID:5297-1667379600-1667406600@bawazirpharma.com
SUMMARY:Advance GMP I Oral Solid Dosage Form 2 November\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  1 November\, 2022.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for implementation. This training will also enhance understanding and be beneficial to persons who work in product development and Technology transfer\, regulatory affairs\, pharmaceutical manufacturers\, production engineering\, site engineering\, project engineering\, Quality Operations\, facility support services etc. \n  \nDownload Brochure Advance GMP I – Oral Solid Dosage Form 02_11_2022\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of SFDA GMP guidelines.\nDescribe the Pharmaceutical Quality System concept\, objectives and state of control.\nUnderstand the life-cycle stages and Management responsibility.\nDescribe the prerequisite for the pharmaceutical quality system.\nUnderstand the principles of developing\, designing and implementing the Pharmaceutical Quality System at Oral Solid manufacturing facility.\n\n  \nKEY TOPICS \n\nPharmaceutical Quality System (PQS)\nPQS- GMP for Medicinal Products\nPersonnel\nPremises and Equipment\nProduction – Oral Solid Dosage Form\nCase studies and Best practices\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nProduction – OSD\nPharma Regulatory Affairs\nProduct Development\nProduction Engineers\nQuality Assurance\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/advance-gmp-i-oral-solid-dosage-form-2-november-2022-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:20221103T090000
DTEND;TZID=Europe/Moscow:20221103T163000
DTSTAMP:20260428T225035
CREATED:20220808T142805Z
LAST-MODIFIED:20221027T111938Z
UID:5303-1667466000-1667493000@bawazirpharma.com
SUMMARY:Advance GMP II Sterile Medicinal Products 3 November\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  2 November\, 2022.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW \nUnderstanding the Pharmaceutical Quality System is an essential skills for people working in pharmaceutical manufacturing industry. This course will provide an overview of the pharmaceutical quality system for sterile medicinal product as specified in SFDA GMP guidelines and prepare for implementation. This one day course is designed to increase their knowledge in contamination control strategy\, specific technologies and will provide a comprehensive\, yet practical assessment of the regulations. \nThis training will also enhance understanding and beneficial to persons who work in product development and Technology transfer\, regulatory compliance\, pharmaceutical manufacturers\, production engineering\, site engineering\, Quality Operations etc. \n  \nDownload Brochure Advance GMP II – Sterile Medicinal Products 03_11_2022\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of Production Technology for sterile medicinal products\nUnderstand the contamination control strategy\nDescribe the premises for a clean area and clean area monitoring\nUnderstand the principles of specific technology for the sterile medicinal product manufacturing\n\n  \nKEY TOPICS \n\nPharmaceutical Quality System (PQS)\nPersonnel\nEquipment\nPremises clean area and monitoring\nProduction Technology\nSpecific Technologies\nProcessing (Production-Sterilization)\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nProduction – OSD\nPharma Regulatory Affairs\nProduct Development\nProduction Engineers\nQuality Assurance\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/advance-gmp-ii-sterile-medicinal-products-3-november-2022-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:20221108T090000
DTEND;TZID=Europe/Moscow:20221108T163000
DTSTAMP:20260428T225035
CREATED:20220808T010853Z
LAST-MODIFIED:20220808T012438Z
UID:5283-1667898000-1667925000@bawazirpharma.com
SUMMARY:Post Approval Activities and Compliance: Variations Guideline 8 November\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 21 October 2022.\n\n\nSAR 1000.00\n\n\n\n\nOVERVIEW\nThis course will provide an overview and analysis of the various regulatory activities that take place post-approval: In particular\, the current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing of notification techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed.  The training will discuss in detail the GCC guideline for variations management and post approval commitment. \n  \nDownload Brochure Post Approval Activities and Compliance_Variations Guideline 8_November_2022\n  \nLEARNING OBJECTIVES \n\nDescribe the role of regulatory affairs on meeting SFDA regulations\nUnderstand the regulatory activities that take place post approval of their products.\nDiscuss the post approval commitment that must be met.\nUnderstand the post approval commitment and how to help company comply with them\n\n  \nKEY TOPICS \n\nPost-approval commitments\nPV\nPSUR\nRMMs\nVariations management\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affair staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager
URL:https://bawazirpharma.com/event/post-approval-activities-and-compliance-variations-guideline-8-november-2022-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:20221108T090000
DTEND;TZID=Europe/Moscow:20221109T163000
DTSTAMP:20260428T225035
CREATED:20221013T135121Z
LAST-MODIFIED:20221013T135121Z
UID:5406-1667898000-1668011400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 8-9 November\, 2022 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 6 November\, 2022.\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 8-9_November_2022 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-8-9-november-2022-riyadh-saudi-arabia/
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:20221114T090000
DTEND;TZID=Europe/Moscow:20221114T163000
DTSTAMP:20260428T225035
CREATED:20221013T141740Z
LAST-MODIFIED:20221025T113604Z
UID:5417-1668416400-1668443400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 14 November\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  13 November 2022.\n\nSAR 1200.00\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  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 Basics of Drug Regulatory Affairs SFDA Explained 14_November_2022 Riyadh\, Saudi Arabia\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
URL:https://bawazirpharma.com/event/basics-of-drug-regulatory-affairs-sfda-system-explained-training-14-november-2022-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
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