Pharmaceutical Products Registration United Arab Emirates

Partner: Udemy
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Description: This course will prepare you, to be an expert in pharmaceutical products placement in the high-potential market of the United Arab Emirates. the business hub of the Middle East region. What will you learn?Introduction to MOHAP LOA eCTDM1 preparation MOHAP e Transformation MOHAP registration Application process Renewal Variation Minor variation Variation listVariation forms AppendicesTracking/tracing  Updates This course will provide you, with all tools that you need to run all regulatory activities related to pharmaceutical products starting from registration, to placing these pharmaceutical products in the high potential diverse market of the UAE, in Dubai, the GCC region business hub. Then to perform post-market placement activities, such as renewal/Checklist/Application and variations “Major/Minor”and variations appendices, in addition to pharmacovigilance.We will take off together to the United Arab Emirates together, starting our journey with the classification, as the basic mandatory step for the regulation of any product ever with any health authority ever. as they do not follow blindly the COO classification.Then we will prepare the LOA, with the explanation of the mandate of either legalization or notarizationWhat is notarization? and the notary list of countries? Then we will transit for a while with UAE eCTD Implementation, and eCTD File Structure, with great focus and deep dive into  M1 insights.We will prepare together the dossier for online submission for the conventional products Products registered before 7 March 2016 need to be reformatted to e-CTD format. The MOHAP e-Transformation was implemented by the MOH of the UAE on 11 April 2019 and is st
Category: Teaching & Academics > Science > Pharmaceutical Industry
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Price: 169.99
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Source: Impact
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