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Master Drug registration Saudi Arabia

Partner: Udemy
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Description: This course will provide you with all the required knowledge, and skills, in addition to the experience from practice to mastering pharmaceutical products in the biggest and most important market ever in the GCC region, the market that could not be missed by any pharmaceutical or healthcare company seeking for a considerable ROI, and achieving the required revenueWhat will you learn?Introduction to SFDA Classification guidelines Guidance for pharmaceutical registration eCTDeCTD M2 to M5Application processTemplates CPPSpecial approaches for registrationSMPCS Registration fees Tracking/tracingClerance By the end of this course, you will be the expert on pharmaceutical products registration, renewal, and variations We will start our journey towards the market of Sudi Arabia by the classification, focusing on the specific situations to classification mismatch between COO and SFDA of Sudi Arabia, these cases which became too many over the past 5 years, not like before, not like other health authorities which usually follow the COO classification.and this topic of classification is so critical, so in this course, you will learn from practice how to proceed with these quite common cases.Then we will go together to the eSDR system to see how the workflow of the pharmaceuticals registration processExploring the eCTD, structure, modules, and checklist of each module, how to prepare the forms and templates that should be there in each module, keep emphasizing again that module 1 is not part of any eCTD, and how to prepare module 1 that specific for SFDA submission in the KSA. Then we will explore what is new in these regulations of the SFDA submission, and the drug application process itself.Afterward, we will explain 2 very speci
Category: Teaching & Academics > Science > Pharmaceutical Industry
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Price: 124.99
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Source: Impact
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