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eCTD Variations & Baseline Conversions
All old formats (MBR/MRF need to be converted to CTD) this is called a baseline dossier with sequence 0000. Once this is done, learn how to distinguish between type Ia, Ib and type II variations (through the EMA variations guidelines) required to be submitted as your product lives out its lifecycle. Compile variations/ amendment changes 0001, 0002 correctly.
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- A R500 enrolment fee applies to all new learners on top of course fees.
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