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:20210101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20220621T090000
DTEND;TZID=Europe/Moscow:20220621T163000
DTSTAMP:20260429T061056
CREATED:20220327T123700Z
LAST-MODIFIED:20220327T123700Z
UID:4990-1655802000-1655829000@bawazirpharma.com
SUMMARY:CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 21 June\, 2022 Riyadh
DESCRIPTION:Note:  All training program require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 7 June\, 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected\, and the formulation proposed are suitable for the intended use. \nThis module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development\, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. \nAs drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increases in parallel. \n  \nDownload Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry\, Manufacturing and Control (CMC) 21 June\, 2022 Riyadh  \n  \nLEARNING OBJECTIVES \n• Define the different types of data requirements for type of product\n• Describe the general CMC requirements for New Drug Application\n• Distinguish CMC information required for special categories\n• Understand the Substance part of the Module\n• Identify the required information for product part of the module\n• Understand how to respond to regulatory authority questions. \nKEY TOPICS \n\nThe CMC aspects of the regulatory submission will cover\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished dosage form\nDescription of the product and process development\nDescription of the manufacturing processes\nRelease and stability testing data for both the active substance and the dosage form\nAnalytical methods and specifications used for testing and release of raw materials\nContainer and closure systems\n\nWHO WILL ATTEND \nProfessionals working in: \n\nRegulatory Affairs staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager.
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-new-chemical-and-generic-products-chemistry-manufacturing-and-control-cmc-21-june-2022-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20220622T090000
DTEND;TZID=Europe/Moscow:20220622T163000
DTSTAMP:20260429T061056
CREATED:20220327T124650Z
LAST-MODIFIED:20220327T124650Z
UID:4993-1655888400-1655915400@bawazirpharma.com
SUMMARY:Pharmaceuticals Pricing\, Reimbursement and Market Access. SFDA System Explained 22 June\, 2022 Riyadh
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 2000.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 7 June 2022. \nSAR 1500.00\n\n\n\nOVERVIEW \nThe rise in costs of pharmaceutical products in general affects all sectors of the \nhealth care industry\, including private insurers and patients. This workshop shall \ngive an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. \nIn addition\, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products. \n  \nDownload Brochure Pharmaceuticals Pricing SFDA System Explained 22 June\, 2022 Riyadh  \n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nUnderstand the history of pharmaceuticals pricing and the different types of pricing modalities.\nUnderstand the principals of SFDA and GCC_DR pricing system.\nHow to prepare your product pricing certificate. How to predict your product pricing\nHow to petition pricing decision.\n\nKEY TOPICS \n\nHistory of Pharmaceuticals pricing.\nModalities of pricing.\nReference pricing and reimbursement.\nPharmacoeconomic.\nPharmaceutical Pricing Policies – Regional Experience\nHow to prepare your pricing certificate?\nHow to predict your product price?\n\nWHO WILL ATTEND \n\nProfessionals working in:\n\nHealthcare Executives.\nEconomists.\nPharmaceutical Industry.\nHealth Insurance Professionals.\nLaw professionals.\nPharma Regulatory Affairs.\nScientific Office Managers.\nRegulatory Authorities.\npharmaceutical manufacturers.\nPharmacist.
URL:https://bawazirpharma.com/event/pharmaceuticals-pricing-reimbursement-and-market-access-sfda-system-explained-22-june-2022-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Moscow:20220627T090000
DTEND;TZID=Europe/Moscow:20220628T170000
DTSTAMP:20260429T061056
CREATED:20220606T085218Z
LAST-MODIFIED:20220703T135032Z
UID:5106-1656320400-1656435600@bawazirpharma.com
SUMMARY:SFDA Pharmacovigilance System Explained 27-28 June_2022\, Riyadh\, Saudi Arabia
DESCRIPTION:Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 4500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 23 June\, 2022.\nSAR 3500.00\n\n\n\nOVERVIEW \nUnderstanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields\, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research\, data management\, basic research\, and marketing\, etc. \n  \nDownload Brochure SFDA Pharmacovigilance System Explained 27-28_June_2022 Riyadh\, Saudi Arabia\n  \nLEARNING OBJECTIVES \nAt the conclusion of this training\, participants will be able to: \n\nDefine the key principles and processes of pharmacovigilance\n\n\nDefine official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System\nDescribe the component of the PV System\nUnderstand the role and responsibilities of the QPPV\nUnderstand national pharmacovigilance sub-system file (national PSSF)\nRecognize SFDA oversight and processes during the post-approval phase.\nUnderstand ADR case assessment\, PSUR and risk management.\nInteract appropriately with the SFDA regarding PV\nUnderstand the process of PV inspection and audits.\n\nKEY TOPICS \n\nIntroduction to Pharmacoepidemiology and Pharmacovigilance\nPharmacovigilance systems and their quality systems\nPharmacovigilance System Master File\nQualified Person Responsible for Pharmacovigilance in Saudi Arabia\nRisk Management Systems\nManagement and Reporting of Adverse Reactions to Medicinal Products\nPeriodic Safety Update Reports\nPost-Authorization Safety Studies\nSignal Management\nSafety Communication\nRisk Minimization Measures\nPharmacovigilance Inspections\nPharmacovigilance Audits\nBasic concepts of vaccines and adverse events following immunization\n\n  \nWHO WILL ATTEND \nProfessionals working in: \n\nQPPV\nPharma Regulatory Affairs\nCountry Managers\nScientific Office Managers\nContract Research Organizations (CROs)\nRegulatory Authorities.\nPharmacist\nCompliance
URL:https://bawazirpharma.com/event/sfda-pharmacovigilance-system-explained-27-28-june_2022-riyadh-saudi-arabia/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
END:VEVENT
END:VCALENDAR