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X-WR-CALNAME:Prof. Bawazir Pharma Consulting Center
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:20200101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20221012T090000
DTEND;TZID=Europe/Moscow:20221012T163000
DTSTAMP:20260425T175149
CREATED:20220804T135727Z
LAST-MODIFIED:20221002T081206Z
UID:5209-1665565200-1665592200@bawazirpharma.com
SUMMARY:CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 12 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 10 October\, 2022. \n\nSAR 1500.00\n\n\n\n\nOVERVIEW \nThe Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected\, and the formulation proposed are suitable for the intended use. \nThis module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development\, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. \nAs drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increases in parallel. \n  \nDownload Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 12 October\, 2022 Riyadh \n  \nLEARNING OBJECTIVES \n• Define the different types of data requirements for type of product\n• Describe the general CMC requirements for New Drug Application\n• Distinguish CMC information required for special categories\n• Understand the Substance part of the Module\n• Identify the required information for product part of the module\n• Understand how to respond to regulatory authority questions. \nKEY TOPICS \n\nThe CMC aspects of the regulatory submission will cover\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished dosage form\nDescription of the product and process development\nDescription of the manufacturing processes\nRelease and stability testing data for both the active substance and the dosage form\nAnalytical methods and specifications used for testing and release of raw materials\nContainer and closure systems\n\nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affairs staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager.
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-new-chemical-and-generic-products-chemistry-manufacturing-and-control-cmc-12-october-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:20221011T090000
DTEND;TZID=Europe/Moscow:20221011T163000
DTSTAMP:20260425T175150
CREATED:20220804T121312Z
LAST-MODIFIED:20221002T080532Z
UID:5198-1665478800-1665505800@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\,  Reimbursement and  Market Access. SFDA System Explained  11 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 9 October 2022. \n\nSAR 1500.00\n\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \n  \nDownload Brochour Pharmaceuticals Pricing SFDA System Explained 11_October_2022\, Riyadh \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-reimbursement-and-market-access-sfda-system-explained-11-october-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:20221003T090000
DTEND;TZID=Europe/Moscow:20221004T170000
DTSTAMP:20260425T175150
CREATED:20220804T085318Z
LAST-MODIFIED:20220920T093757Z
UID:5176-1664787600-1664902800@bawazirpharma.com
SUMMARY:Advance Pharmacovigilance 3-4 October\, 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 29th September\, 2022.\nSAR 3500.00\n\n\n\nOVERVIEW \nThis two-day course is designed for those who look to increase their knowledge in drug safety and will provide a comprehensive\, yet practical assessment of the main regulations required to comply with SFDA regulations. \n  \nDownload Brochure Advance Pharmacovigilance 3-4 October\, 2022 Riyadh\, Saudi Arabia \n  \nKEY TOPICS \n\nPharmacoepidemiological methods\nManagement of PharmacovigilanceData\nSpontaneous Case Processing\nLiterature searching\nPharmacovigilance methods\nSignal detection\nCausality assessment\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\n\n 
URL:https://bawazirpharma.com/event/advance-pharmacovigilance-3-4-october-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:20220927T090000
DTEND;TZID=Europe/Moscow:20220928T170000
DTSTAMP:20260425T175150
CREATED:20220804T073733Z
LAST-MODIFIED:20220920T093336Z
UID:5165-1664269200-1664384400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 27-28 September_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 26 September\, 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 27-28_Sept_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-27-28-september_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:20220926T090000
DTEND;TZID=Europe/Moscow:20220926T163000
DTSTAMP:20260425T175150
CREATED:20220804T092323Z
LAST-MODIFIED:20220804T092620Z
UID:5184-1664182800-1664209800@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 26 September\, 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 September 2022.\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  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 26_Sept_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-26-september-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:20220627T090000
DTEND;TZID=Europe/Moscow:20220628T170000
DTSTAMP:20260425T175150
CREATED:20220606T085218Z
LAST-MODIFIED:20220703T135032Z
UID:5106-1656320400-1656435600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 27-28 June_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 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 23 June\, 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 27-28_June_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-27-28-june_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:20220622T090000
DTEND;TZID=Europe/Moscow:20220622T163000
DTSTAMP:20260425T175150
CREATED:20220327T124650Z
LAST-MODIFIED:20220327T124650Z
UID:4993-1655888400-1655915400@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 22 June\, 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 7 June 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \n  \nDownload Brochure Pharmaceuticals Pricing SFDA System Explained 22 June\, 2022 Riyadh  \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-reimbursement-and-market-access-sfda-system-explained-22-june-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:20220621T090000
DTEND;TZID=Europe/Moscow:20220621T163000
DTSTAMP:20260425T175150
CREATED:20220327T123700Z
LAST-MODIFIED:20220327T123700Z
UID:4990-1655802000-1655829000@bawazirpharma.com
SUMMARY:CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 21 June\, 2022 Riyadh
DESCRIPTION:Note:  All training program 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 7 June\, 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected\, and the formulation proposed are suitable for the intended use. \nThis module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development\, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. \nAs drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increases in parallel. \n  \nDownload Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 21 June\, 2022 Riyadh  \n  \nLEARNING OBJECTIVES \n• Define the different types of data requirements for type of product\n• Describe the general CMC requirements for New Drug Application\n• Distinguish CMC information required for special categories\n• Understand the Substance part of the Module\n• Identify the required information for product part of the module\n• Understand how to respond to regulatory authority questions. \nKEY TOPICS \n\nThe CMC aspects of the regulatory submission will cover\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished dosage form\nDescription of the product and process development\nDescription of the manufacturing processes\nRelease and stability testing data for both the active substance and the dosage form\nAnalytical methods and specifications used for testing and release of raw materials\nContainer and closure systems\n\nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affairs staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager.
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-new-chemical-and-generic-products-chemistry-manufacturing-and-control-cmc-21-june-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:20220530T090000
DTEND;TZID=Europe/Moscow:20220530T163000
DTSTAMP:20260425T175150
CREATED:20220327T122253Z
LAST-MODIFIED:20220327T122253Z
UID:4987-1653901200-1653928200@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 30 May\, 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 18 May\, 2022. \nSAR 1500.00\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 30 May 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-30-may-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:20220524T090000
DTEND;TZID=Europe/Moscow:20220525T163000
DTSTAMP:20260425T175150
CREATED:20220327T121037Z
LAST-MODIFIED:20220327T121037Z
UID:4984-1653382800-1653496200@bawazirpharma.com
SUMMARY:Advance Pharmacovigilance 24-25 May\, 2022 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training program require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 16 May\, 2022.\nSAR 3500.00\n\n\n\nOVERVIEW \nThis two-day course is designed for those who look to increase their knowledge in drug safety and will provide a comprehensive\, yet practical assessment of the main regulations required to comply with SFDA regulations. \nDownload Brochure Advance Pharmacovigilance 24-25 May\, 2022 Riyadh\, Saudi Arabia  \n  \nKEY TOPICS \n\nPharmacoepidemiological methods\nManagement of PharmacovigilanceData\nSpontaneous Case Processing\nLiterature searching\nPharmacovigilance methods\nSignal detection\nCausality assessment\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\n\n 
URL:https://bawazirpharma.com/event/advance-pharmacovigilance-24-25-may-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:20220518T090000
DTEND;TZID=Europe/Moscow:20220518T163000
DTSTAMP:20260425T175150
CREATED:20220327T115317Z
LAST-MODIFIED:20220327T115317Z
UID:4979-1652864400-1652891400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 18 May\, 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 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  11 May 2022.\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  \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 18_May_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-18-may-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:20220516T090000
DTEND;TZID=Europe/Moscow:20220517T163000
DTSTAMP:20260425T175150
CREATED:20220327T113504Z
LAST-MODIFIED:20220327T113504Z
UID:4981-1652691600-1652805000@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 16-17 May_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 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 11 May\, 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 16-17_May_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-16-17-may_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:20220314T090000
DTEND;TZID=Europe/Moscow:20220314T170000
DTSTAMP:20260425T175150
CREATED:20220208T130936Z
LAST-MODIFIED:20220209T070713Z
UID:4868-1647248400-1647277200@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 14 March\, 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 10 March 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \n  \nDownload Brochure Pharmaceuticals Pricing SFDA System Explained 14 March\, 2022 Riyadh \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-reimbursement-and-market-access-sfda-system-explained-14-march-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:20220309T090000
DTEND;TZID=Europe/Moscow:20220309T170000
DTSTAMP:20260425T175150
CREATED:20220208T121958Z
LAST-MODIFIED:20220208T130957Z
UID:4865-1646816400-1646845200@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 9 March\, 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 5 March\, 2022. \nSAR 1500.00\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 9 March 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-9-march-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:20220308T090000
DTEND;TZID=Europe/Moscow:20220308T170000
DTSTAMP:20260425T175150
CREATED:20220208T113614Z
LAST-MODIFIED:20220209T080325Z
UID:4855-1646730000-1646758800@bawazirpharma.com
SUMMARY:CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 8 March\, 2022 Riyadh
DESCRIPTION:Note:  All training program 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 3 March\, 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected\, and the formulation proposed are suitable for the intended use. \nThis module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development\, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. \nAs drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increases in parallel. \n  \nDownload Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 8 March\, 2022 Riyadh \n  \nLEARNING OBJECTIVES \n• Define the different types of data requirements for type of product\n• Describe the general CMC requirements for New Drug Application\n• Distinguish CMC information required for special categories\n• Understand the Substance part of the Module\n• Identify the required information for product part of the module\n• Understand how to respond to regulatory authority questions. \nKEY TOPICS \n\nThe CMC aspects of the regulatory submission will cover\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished dosage form\nDescription of the product and process development\nDescription of the manufacturing processes\nRelease and stability testing data for both the active substance and the dosage form\nAnalytical methods and specifications used for testing and release of raw materials\nContainer and closure systems\n\nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affairs staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager.
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-new-chemical-and-generic-products-chemistry-manufacturing-and-control-cmc-8-march-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:20220301T090000
DTEND;TZID=Europe/Moscow:20220302T170000
DTSTAMP:20260425T175150
CREATED:20220206T074040Z
LAST-MODIFIED:20220208T115821Z
UID:4843-1646125200-1646240400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 1-2 March_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 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 24 February\, 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 1-2_March_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-1-2-march_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:20220209T090000
DTEND;TZID=Europe/Moscow:20220209T170000
DTSTAMP:20260425T175150
CREATED:20220115T185546Z
LAST-MODIFIED:20220209T070629Z
UID:4824-1644397200-1644426000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 9 February\, 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 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  3 February 2022.\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  \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 9_February_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-9-february-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:20220117T090000
DTEND;TZID=Europe/Moscow:20220118T170000
DTSTAMP:20260425T175150
CREATED:20211221T221426Z
LAST-MODIFIED:20211221T221458Z
UID:4762-1642410000-1642525200@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 17-18 January\, 2022 Riyadh
DESCRIPTION:Note:  All training programs require physical present and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 14 January\, 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 17-18 January 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-17-18-january-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:20220110T090000
DTEND;TZID=Europe/Moscow:20220110T170000
DTSTAMP:20260425T175150
CREATED:20211215T144347Z
LAST-MODIFIED:20211215T180756Z
UID:4716-1641805200-1641834000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 10 January\, 2022 Riyadh
DESCRIPTION:Note:  All training programs require physical present and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  07 January 2022.\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  \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 10_January_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-10-january-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:20211123T090000
DTEND;TZID=Europe/Moscow:20211124T173000
DTSTAMP:20260425T175150
CREATED:20211027T132332Z
LAST-MODIFIED:20211027T132644Z
UID:4655-1637658000-1637775000@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 23-24 November\, 2021 Riyadh
DESCRIPTION:Note:  All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 19 November\, 2021.\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 23-24 2021 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\n\n 
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-23-24-november-2021-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:20211117T090000
DTEND;TZID=Europe/Moscow:20211117T170000
DTSTAMP:20260425T175150
CREATED:20211027T120251Z
LAST-MODIFIED:20211027T133240Z
UID:4651-1637139600-1637168400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 17 November\, 2021 Riyadh
DESCRIPTION:Note:  All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  12 November 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  \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 17_November_2021 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-17-november-2021-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:20211026T090000
DTEND;TZID=Europe/Moscow:20211026T170000
DTSTAMP:20260425T175150
CREATED:20210920T170731Z
LAST-MODIFIED:20210921T082238Z
UID:4553-1635238800-1635267600@bawazirpharma.com
SUMMARY:CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 26 October\, 2021 Riyadh
DESCRIPTION:Note:  All training program require physical presnt 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 23 October\, 2021. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected\, and the formulation proposed are suitable for the intended use. \nThis module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development\, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. \nAs drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increases in parallel. \nDownload Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 26 October\, 2021 Riyadh \n  \nLEARNING OBJECTIVES \n• Define the different types of data requirements for type of product\n• Describe the general CMC requirements for New Drug Application\n• Distinguish CMC information required for special categories\n• Understand the Substance part of the Module\n• Identify the required information for product part of the module\n• Understand how to respond to regulatory authority questions. \nKEY TOPICS \n\nThe CMC aspects of the regulatory submission will cover\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished dosage form\nDescription of the product and process development\nDescription of the manufacturing processes\nRelease and stability testing data for both the active substance and the dosage form\nAnalytical methods and specifications used for testing and release of raw materials\nContainer and closure systems\n\nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affairs staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager.
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-new-chemical-and-generic-products-chemistry-manufacturing-and-control-cmc-26-october-2021-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:20211019T090000
DTEND;TZID=Europe/Moscow:20211020T173000
DTSTAMP:20260425T175150
CREATED:20210920T163049Z
LAST-MODIFIED:20210920T182414Z
UID:4544-1634634000-1634751000@bawazirpharma.com
SUMMARY:Advance Pharmacovigilance 19-20 October\, 2021 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 17 October\, 2021.\nSAR 3500.00\n\n\n\nOVERVIEW \nThis two-day course is designed for those who look to increase their knowledge in drug safety and will provide a comprehensive\, yet practical assessment of the main regulations required to comply with SFDA regulations. \nDownload Brochure Advance Pharmacovigilance 19-20 October\, 2021 Riyadh\, Saudi Arabia \n  \nKEY TOPICS \n\nPharmacoepidemiological methods\nManagement of PharmacovigilanceData\nSpontaneous Case Processing\nLiterature searching\nPharmacovigilance methods\nSignal detection\nCausality assessment\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\n\n 
URL:https://bawazirpharma.com/event/advance-pharmacovigilance-19-20-october-2021-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:20211012T090000
DTEND;TZID=Europe/Moscow:20211012T170000
DTSTAMP:20260425T175150
CREATED:20210920T161337Z
LAST-MODIFIED:20210920T182040Z
UID:4541-1634029200-1634058000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 12 October\, 2021 Riyadh
DESCRIPTION:Note:  All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  10 October 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. \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 12_October_2021 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-12-october-2021-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:20210914T090000
DTEND;TZID=Europe/Moscow:20210914T173000
DTSTAMP:20260425T175150
CREATED:20210809T123647Z
LAST-MODIFIED:20210809T124039Z
UID:4460-1631610000-1631640600@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 14 September\, 2021 Riyadh
DESCRIPTION:  \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 10 September 2021. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \nDownload Brochure Pharmaceuticals Pricing SFDA System Explained 14 September\, 2021 Riyadh \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-reimbursement-and-market-access-sfda-system-explained-14-september-2021-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:20210913T090000
DTEND;TZID=Europe/Moscow:20210913T173000
DTSTAMP:20260425T175150
CREATED:20210809T113430Z
LAST-MODIFIED:20210809T120214Z
UID:4446-1631523600-1631554200@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 13 September\, 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  9 September 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. \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 13_September_2021 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-13-september-2021-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:20210907T090000
DTEND;TZID=Europe/Moscow:20210908T173000
DTSTAMP:20260425T175150
CREATED:20210802T135341Z
LAST-MODIFIED:20210802T135542Z
UID:4428-1631005200-1631122200@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 7-8 Sebtember\, 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 03rd September\, 2021.\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 7-8 September 2021 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\n\n 
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-7-8-sebtember-2021-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:20210706T090000
DTEND;TZID=Europe/Moscow:20210707T173000
DTSTAMP:20260425T175150
CREATED:20210607T103312Z
LAST-MODIFIED:20210613T122039Z
UID:4385-1625562000-1625679000@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 6-7 July\, 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 01st July\, 2021.\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 July 2021 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\n\n 
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-6-7-july-2021-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:20210601T090000
DTEND;TZID=Europe/Moscow:20210601T173000
DTSTAMP:20260425T175150
CREATED:20210428T131007Z
LAST-MODIFIED:20210429T105951Z
UID:4304-1622538000-1622568600@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 1 June\, 2021 Riyadh
DESCRIPTION:  \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 31  May 2021. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \nDownload Brochure Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 1 June\, 2021 Riyadh\, Saudi Arabia \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-sfda-system-explained-1-june-2021-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:20210531T090000
DTEND;TZID=Europe/Moscow:20210531T170000
DTSTAMP:20260425T175150
CREATED:20210428T110009Z
LAST-MODIFIED:20210428T110704Z
UID:4297-1622451600-1622480400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 31 May\, 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  30 May 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. \nDownload Brochure Basics of Drug Regulatory Affairs SFDA Explained 31_May_2021 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-31-may-2021-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
END:VCALENDAR