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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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DTSTART;TZID=Europe/Moscow:20210302T090000
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DTSTAMP:20260425T152759
CREATED:20210126T160709Z
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SUMMARY:CTD Quality Module 3 For health and herbal products Chemistry Manufacturing and Control (CMC) Of product quality requirements 2 March\, 2021 Riyadh
DESCRIPTION:  \n\n\n\nFEES\nSAUDI RIYAL\n\n\nREGISTRATION FEES \nSAR 1500.00\n\n\nEARLY BIRDS REGISTRATION FEE  \nPAY YOUR FEE BEFORE 24th February 2021. \nSAR 1000.00\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. This 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. As drug development of the dosage form moves from concept to commercialization\, the breadth and depth of CMC documentation required in submissions increase in parallel. \n  \nLEARNING OBJECTIVES \n\nDefine the different types of data requirements for type of product\nDescribe the general CMC requirements for New Drug Application\nDistinguish CMC information required for special categories\nUnderstand the Substance part of the Module\nIdentify the required information for product part of the module\nUnderstand how to respond to regulatory authority questions.\n\nKEY TOPICS \nThe CMC aspects of the regulatory submission will cover: \n\nCharacterization of the active substance\nRaw materials used to manufacture the active substance and finished\ndosage 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 Affair staff\nScientific office staff\nProduction manager\nQA Manger\nQC Manager
URL:https://bawazirpharma.com/event/ctd-quality-module-3-for-health-and-herbal-products-chemistry-manufacturing-and-control-cmc-of-product-quality-requirements-2-march-2021-riyadh/
LOCATION:Bawazir Pharma Office\, PJW5+79\, Riyadh\, 13513\, Saudi Arabia
ORGANIZER;CN="Bawazir Pharma Consulting":MAILTO:info@bawazirpharma.com
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