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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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DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20231002T090000
DTEND;TZID=Europe/Moscow:20231002T160000
DTSTAMP:20260428T065720
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
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20231003T090000
DTEND;TZID=Europe/Moscow:20231003T160000
DTSTAMP:20260428T065720
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
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BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20231009T090000
DTEND;TZID=Europe/Moscow:20231010T160000
DTSTAMP:20260428T065720
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
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