BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Prof. Bawazir Pharma Consulting Center - ECPv6.15.20//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Prof. Bawazir Pharma Consulting Center
X-ORIGINAL-URL:https://bawazirpharma.com
X-WR-CALDESC:Events for Prof. Bawazir Pharma Consulting Center
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Europe/Moscow
BEGIN:STANDARD
TZOFFSETFROM:+0300
TZOFFSETTO:+0300
TZNAME:MSK
DTSTART:20220101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20250420T090000
DTEND;TZID=Europe/Moscow:20250420T160000
DTSTAMP:20260425T133455
CREATED:20250403T233610Z
LAST-MODIFIED:20250413T071543Z
UID:7009-1745139600-1745164800@bawazirpharma.com
SUMMARY:Advance Regulatory Understanding SFDA Drug Pricing System\, Reimbursement and Market Access. 20 April\, 2025 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 18 April 2025. \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 Brochure Advance Regulatory Understanding SFDA Drug Pricing System\, Reimbursement and Market Access 20 April 2025 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/advance-regulatory-understanding-sfda-drug-pricing-system-reimbursement-and-market-access-20-april-2025-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:20250410T090000
DTEND;TZID=Europe/Moscow:20250410T160000
DTSTAMP:20260425T133455
CREATED:20250403T141921Z
LAST-MODIFIED:20260321T013301Z
UID:6993-1744275600-1744300800@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 10 April 2025 Riyadh
DESCRIPTION:Date of training 10 April 2025 Riyadh Saudi Arabia \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 7 April 2025. \n\nSAR 1500.00\n\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 
URL:https://bawazirpharma.com/event/common-technical-documents-ctd-and-ectd-preparation-10-april-2025-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:20250203T090000
DTEND;TZID=Europe/Moscow:20250203T160000
DTSTAMP:20260425T133455
CREATED:20241229T202306Z
LAST-MODIFIED:20250130T111044Z
UID:6927-1738573200-1738598400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 3 February 2025 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3400.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  30  JANUARY 2025.\n\nSAR 2400.00\n\n\n\n\nOVERVIEW \nUnderstanding drug regulatory affairs 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 3 February 2025 Riyadh\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.\nDefine official regulatory policies and other issues pertinent to a successful SFDA regulatory strategy.\nDescribe key differences between National and the Gulf Cooperation Council Drug Registration 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.\nRecognize 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-3-february-2025-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:20250113T090000
DTEND;TZID=Europe/Moscow:20250114T163000
DTSTAMP:20260425T133455
CREATED:20241225T132521Z
LAST-MODIFIED:20241225T132921Z
UID:6913-1736758800-1736872200@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 13-14 January 2025 Riyadh Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 11 January 2025.\nSAR 5200.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_13-14 January_2025 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-13-14-january-2025-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:20241217T090000
DTEND;TZID=Europe/Moscow:20241218T160000
DTSTAMP:20260425T133455
CREATED:20241124T215537Z
LAST-MODIFIED:20241211T104511Z
UID:6819-1734426000-1734537600@bawazirpharma.com
SUMMARY:Advance Comprehensive Pharmacovigilance Training 17-18 December 2024 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 6500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 16th December\, 2024.\nSAR 5200.00\n\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 Comprehensive Pharmacovigilance Training 17-18 December 2024 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
URL:https://bawazirpharma.com/event/advance-comprehensive-pharmacovigilance-training-17-18-december-2024-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:20241209T090000
DTEND;TZID=Europe/Moscow:20241209T160000
DTSTAMP:20260425T133455
CREATED:20241119T202756Z
LAST-MODIFIED:20241119T202756Z
UID:6805-1733734800-1733760000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 9 December 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3400.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  6  December 2024.\n\nSAR 2400.00\n\n\n\n\nOVERVIEW \nUnderstanding drug regulatory affairs 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 9 December 2024 Riyadh\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.\nDefine official regulatory policies and other issues pertinent to a successful SFDA regulatory strategy.\nDescribe key differences between National and the Gulf Cooperation Council Drug Registration 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.\nRecognize SFDA oversight and processes during the post-approval phase.\nInteract appropriately with the SFDA during all phases of drug registration\nUnderstand the regulatory requirements for prescription drug labelling and advertising/promotion.\n\n  \nKEY TOPICS \n\nPrincipals of Regulatory Affairs (RA) and Legal Framework\nSFDA overview and pharmaceutical institutions licensing\nPrinciples of Products licensing and Evaluation\nGMP Inspection and Products Pricing\nOverview of the pharmacovigilance system\nPrinciples of Products Classifications and Listing\nProducts Import\, Release and Advertising\nOverview of the SFDA Electronic systems\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nFresh Graduate\nScientific Office Managers\nRegulatory Authorities.\nDossier Management\nPharmacist\nCompliance\n\n 
URL:https://bawazirpharma.com/event/basics-of-drug-regulatory-affairs-sfda-system-explained-training-9-december-2024-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:20241022T090000
DTEND;TZID=Europe/Moscow:20241023T163000
DTSTAMP:20260425T133455
CREATED:20240926T032915Z
LAST-MODIFIED:20240926T032915Z
UID:6729-1729587600-1729701000@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 22-23 October 2024 Riyadh Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 18 October 2024.\nSAR 5200.00\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\n  \nDownload Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_22-23_October_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-22-23-october-2024-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:20241021T090000
DTEND;TZID=Europe/Moscow:20241021T160000
DTSTAMP:20260425T133455
CREATED:20240926T025052Z
LAST-MODIFIED:20240929T093856Z
UID:6726-1729501200-1729526400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 21 October 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3400.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  18  October 2024.\n\nSAR 2400.00\n\n\n\n\nOVERVIEW \nUnderstanding drug regulatory affairs 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 21 October 2024 Riyadh\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.\nDefine official regulatory policies and other issues pertinent to a successful SFDA regulatory strategy.\nDescribe key differences between National and the Gulf Cooperation Council Drug Registration 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.\nRecognize SFDA oversight and processes during the post-approval phase.\nInteract appropriately with the SFDA during all phases of drug registration\nUnderstand the regulatory requirements for prescription drug labelling and advertising/promotion.\n\n  \nKEY TOPICS \n\nPrincipals of Regulatory Affairs (RA) and Legal Framework\nSFDA overview and pharmaceutical institutions licensing\nPrinciples of Products licensing and Evaluation\nGMP Inspection and Products Pricing\nOverview of the pharmacovigilance system\nPrinciples of Products Classifications and Listing\nProducts Import\, Release and Advertising\nOverview of the SFDA Electronic systems\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nPharma Regulatory Affairs\nFresh Graduate\nScientific Office Managers\nRegulatory Authorities.\nDossier Management\nPharmacist\nCompliance\n\n 
URL:https://bawazirpharma.com/event/basics-of-drug-regulatory-affairs-sfda-system-explained-training-21-october-2024-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:20240826T090000
DTEND;TZID=Europe/Moscow:20240827T163000
DTSTAMP:20260425T133455
CREATED:20240730T205616Z
LAST-MODIFIED:20240730T205616Z
UID:6660-1724662800-1724776200@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 26-27 August 2024 Riyadh Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 22 August 2024.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_26-27_August_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-26-27-august-2024-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:20240820T090000
DTEND;TZID=Europe/Moscow:20240820T160000
DTSTAMP:20260425T133455
CREATED:20240730T202418Z
LAST-MODIFIED:20240730T202418Z
UID:6650-1724144400-1724169600@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 20 August 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  17  August 2024.\n\nSAR 1700.00\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 20 August 2024 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-20-august-2024-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:20240715T090000
DTEND;TZID=Europe/Moscow:20240715T160000
DTSTAMP:20260425T133455
CREATED:20240703T145759Z
LAST-MODIFIED:20240703T145759Z
UID:6583-1721034000-1721059200@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 15 July 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  12  July 2024.\n\nSAR 1700.00\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 15 July 2024 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-15-july-2024-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:20240709T090000
DTEND;TZID=Europe/Moscow:20240710T163000
DTSTAMP:20260425T133455
CREATED:20240630T182842Z
LAST-MODIFIED:20240630T182842Z
UID:6564-1720515600-1720629000@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 9-10 July 2024 Riyadh Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 8 July\, 2024.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_9-10_July_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-9-10-july-2024-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:20240610T090000
DTEND;TZID=Europe/Moscow:20240610T160000
DTSTAMP:20260425T133455
CREATED:20240518T231622Z
LAST-MODIFIED:20240518T231622Z
UID:6485-1718010000-1718035200@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 10 June 2024 Riyadh
DESCRIPTION:Note:  This 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 June 2024. \n\nSAR 1500.00\n\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 10_June_2024 Riyadh\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-10-june-2024-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:20240609T090000
DTEND;TZID=Europe/Moscow:20240609T163000
DTSTAMP:20260425T133455
CREATED:20240518T222237Z
LAST-MODIFIED:20240518T225919Z
UID:6398-1717923600-1717950600@bawazirpharma.com
SUMMARY:Online Basic of Good Manufacturing Practice (GMP) SFDA Explained 9 June 2024 Riyadh
DESCRIPTION:Note: Online training program.\nLink will be sent one day before the training day\n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  5 June 2024.\n\n\nSAR 2500.00\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  \nOnline\nDownload Brochure Online Basics of Good Manufacturing Practice (GMP) SFDA Explained 9 June 2024\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
URL:https://bawazirpharma.com/event/online-basic-of-good-manufacturing-practice-gmp-sfda-explained-9-june-2024-riyadh/
LOCATION:Online\, Online
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20240604T090000
DTEND;TZID=Europe/Moscow:20240605T163000
DTSTAMP:20260425T133455
CREATED:20240518T130324Z
LAST-MODIFIED:20240518T130639Z
UID:6459-1717491600-1717605000@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 4-5 June 2024 Riyadh Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 2 June\, 2024.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_4-5_June_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-4-5-june-2024-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:20240603T090000
DTEND;TZID=Europe/Moscow:20240603T160000
DTSTAMP:20260425T133455
CREATED:20240518T061547Z
LAST-MODIFIED:20240518T122307Z
UID:6445-1717405200-1717430400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 3 June 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  31  May 2024.\n\nSAR 1700.00\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 3 June\, 2024 Riyadh Saudi\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-3-june-2024-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:20240429T090000
DTEND;TZID=Europe/Moscow:20240429T160000
DTSTAMP:20260425T133455
CREATED:20240329T010231Z
LAST-MODIFIED:20240329T015425Z
UID:6386-1714381200-1714406400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 29 April\, 2024 Riyadh
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  25  April 2024.\n\nSAR 1700.00\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 29 April 2024 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-29-april-2024-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:20240416T090000
DTEND;TZID=Europe/Moscow:20240417T163000
DTSTAMP:20260425T133455
CREATED:20240329T001459Z
LAST-MODIFIED:20240329T001459Z
UID:6376-1713258000-1713371400@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 16-17 April 2024 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 15 April\, 2024.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_16-17_April_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-16-17-april-2024-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:20240228T090000
DTEND;TZID=Europe/Moscow:20240228T160000
DTSTAMP:20260425T133455
CREATED:20240214T102903Z
LAST-MODIFIED:20240214T102903Z
UID:6353-1709110800-1709136000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 28 February\, 2024 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 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  27  February 2024.\n\nSAR 1700.00\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 28 February 2024 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-28-february-2024-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:20240206T090000
DTEND;TZID=Europe/Moscow:20240207T163000
DTSTAMP:20260425T133455
CREATED:20240109T094716Z
LAST-MODIFIED:20240109T094743Z
UID:6300-1707210000-1707323400@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 6-7 February 2024 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 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 5 February\, 2024.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_6-7_Feb_2024 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\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-6-2-february-2024-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:20240115T090000
DTEND;TZID=Europe/Moscow:20240115T160000
DTSTAMP:20260425T133455
CREATED:20231207T100957Z
LAST-MODIFIED:20231207T100957Z
UID:6256-1705309200-1705334400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 15 January\, 2024 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 3000.00\n\n\nEARLY BIRD REGISTRATION FEE  \nPAY YOUR FEE BEFORE  11  January 2024.\n\nSAR 1700.00\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 15 January 2024 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-15-january-2024-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:20231226T090000
DTEND;TZID=Europe/Moscow:20231227T163000
DTSTAMP:20260425T133455
CREATED:20231130T093828Z
LAST-MODIFIED:20231130T200551Z
UID:6241-1703581200-1703694600@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 26-27 December\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 24 December\, 2023.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_26-27_December_2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-26-27-december-2023-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:20231122T090000
DTEND;TZID=Europe/Moscow:20231122T160000
DTSTAMP:20260425T133455
CREATED:20231022T110702Z
LAST-MODIFIED:20231022T110702Z
UID:6198-1700643600-1700668800@bawazirpharma.com
SUMMARY:Common Technical Documents (CTD) and (eCTD) preparation 22 November 2023 Riyadh
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 20 November 2023. \n\nSAR 1500.00\n\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 22_November_2023 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-22-november-2023-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:20231114T090000
DTEND;TZID=Europe/Moscow:20231115T163000
DTSTAMP:20260425T133455
CREATED:20231019T094628Z
LAST-MODIFIED:20231019T193306Z
UID:6186-1699952400-1700065800@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 14-15 November\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 12 November\, 2023.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_14-15_November_2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\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/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-14-15-november-2023-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:20231009T090000
DTEND;TZID=Europe/Moscow:20231010T160000
DTSTAMP:20260425T133455
CREATED:20230916T133412Z
LAST-MODIFIED:20231005T141614Z
UID:6104-1696842000-1696953600@bawazirpharma.com
SUMMARY:Advance Comprehensive Pharmacovigilance Training 9-10 October 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 8th October\, 2023.\nSAR 4000.00\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 Comprehensive Pharmacovigilance Training 9-10 October 2023 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
URL:https://bawazirpharma.com/event/advance-comprehensive-pharmacovigilance-training-9-10-october-2023-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:20231003T090000
DTEND;TZID=Europe/Moscow:20231003T160000
DTSTAMP:20260425T133455
CREATED:20230915T172939Z
LAST-MODIFIED:20230915T174407Z
UID:6086-1696323600-1696348800@bawazirpharma.com
SUMMARY:Advance Regulatory Understanding SFDA Drug Pricing System\, Reimbursement and Market Access. 3 October 2023 Riyadh
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 29 September 2023. \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. \nDownload Brochure Advance Regulatory Understanding SFDA Drug Pricing System\, Reimbursement and Market Access 3 October 2023 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/advance-regulatory-understanding-sfda-drug-pricing-system-reimbursement-and-market-access-3-october-2023-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:20231002T090000
DTEND;TZID=Europe/Moscow:20231002T160000
DTSTAMP:20260425T133455
CREATED:20230915T135020Z
LAST-MODIFIED:20230915T135020Z
UID:6074-1696237200-1696262400@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 2 October\, 2023 Riyadh
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 3000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  29  September 2023.\n\nSAR 1700.00\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 2 October 2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes 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-2-october-2023-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:20230919T090000
DTEND;TZID=Europe/Moscow:20230920T163000
DTSTAMP:20260425T133455
CREATED:20230905T093935Z
LAST-MODIFIED:20230905T114539Z
UID:6054-1695114000-1695227400@bawazirpharma.com
SUMMARY:Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 19-20_September\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 18 September\, 2023.\nSAR 4500.00\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 Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_19-20_Sept_2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/comprehensive-sfda-pharmacovigilance-system-explained-basic-and-intermediate-19-20_september-2023-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:20230822T090000
DTEND;TZID=Europe/Moscow:20230823T163000
DTSTAMP:20260425T133455
CREATED:20230801T115452Z
LAST-MODIFIED:20230801T115452Z
UID:6028-1692694800-1692808200@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 22-23_August\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 6000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 18 August\, 2023.\nSAR 4500.00\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_22-23_Aug_2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-22-23_august-2023-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:20230613T090000
DTEND;TZID=Europe/Moscow:20230614T160000
DTSTAMP:20260425T133455
CREATED:20230524T141202Z
LAST-MODIFIED:20230524T141202Z
UID:5977-1686646800-1686758400@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 13-14 June\, 2023 Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 5500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 4 June\, 2023.\nSAR 4500.00\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 _13-14_June_2023 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-13-14-june-2023-riyadh-saudi-arabia/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
END:VCALENDAR