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PRODID:-//Prof. Bawazir Pharma Consulting Center - ECPv6.15.20//NONSGML v1.0//EN
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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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TZID:Europe/Moscow
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TZOFFSETFROM:+0300
TZOFFSETTO:+0300
TZNAME:MSK
DTSTART:20220101T000000
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END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230515T090000
DTEND;TZID=Europe/Moscow:20230516T163000
DTSTAMP:20260428T141113
CREATED:20230403T134125Z
LAST-MODIFIED:20230403T134125Z
UID:5874-1684141200-1684254600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 15-16 May\, 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 10 May\, 2023.\nSAR 4000.00\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 _15-16_May_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-15-16-may-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:20230517T090000
DTEND;TZID=Europe/Moscow:20230517T163000
DTSTAMP:20260428T141113
CREATED:20230404T120806Z
LAST-MODIFIED:20230404T120806Z
UID:5885-1684314000-1684341000@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 17 May\, 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 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE  15 May 2023.\n\nSAR 1500.00\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 17 May 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-17-may-2023-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20230522T090000
DTEND;TZID=Europe/Moscow:20230522T163000
DTSTAMP:20260428T141113
CREATED:20230502T120001Z
LAST-MODIFIED:20230502T120001Z
UID:5909-1684746000-1684773000@bawazirpharma.com
SUMMARY:Understanding Biological Good Manufacturing Practice GMP 22 May 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  18 May\, 2023.\n\n\nSAR 2000.00\n\n\n\n\nOVERVIEW \nUnderstanding basics of Biological GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to biological GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices\, regulatory affairs\, pharmaceutical manufacturers\, data management\, basic research\, project management and marketing\, etc. \n  \nDownload Brochure Understanding Biological Good Manufacturing Practice (GMP) 22_May_2023\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the principals of biological manufacturing.\nDescribe the components for Bio- pharmaceutical industry.\nUnderstand Host systems.\nUnderstand bioreactor systems and bioreactor modes\nUnderstand Bioprocess Engineering\nUnderstand Mammalian bioprocess\nUnderstand Cell Growth Curve and biological data and analysis\nDescribe Cell banking system\n\n  \nKEY TOPICS \n\nBio-Pharmaceutical Industry\nQuality Management\nPersonnel\nBioprocess Engineering\nMammalian Bioprocess\nCell Banking System\n\nWHO WILL ATTEND \nProfessionals working in: \n\nProduction manager\nQA manager\nQC manager\nPharma Regulatory Affairs\nScientific Office Managers\nRegulatory Authorities.\nBio & pharmaceutical manufacturers\nPharmacists\nBioprocess team\nCRO staff
URL:https://bawazirpharma.com/event/understanding-biological-good-manufacturing-practice-gmp-22-may-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:20230531T090000
DTEND;TZID=Europe/Moscow:20230531T163000
DTSTAMP:20260428T141113
CREATED:20230514T112449Z
LAST-MODIFIED:20230517T085751Z
UID:5945-1685523600-1685550600@bawazirpharma.com
SUMMARY:Basics of Drug Regulatory Affairs SFDA System Explained Training 31 May 2023 Jeddah
DESCRIPTION:Note:  This training require physical presence and will be held in Jeddah \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 10000.00\n\n\n\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  \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-2023-jeddah/
LOCATION:Centro Salama Hotel\, Centro Salama Al Madinah Al Munwarrah Street Jeddah Saudi Arabia\, Jeddah\, Makkah\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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