AllesEra Academy

Aspiring regulatory affairs

Read a dossier, and brief a publisher, with confidence.

For people entering RA who need to understand a CTD and an eCTD sequence for Egypt and ICH.

Modules

1. CTD in five modules · ~25 min
   • Module 1 is the regional administrative section; Modules 2 to 5 carry quality, non-clinical, and clinical content
   • A variation names one change, so you learn to scope it rather than resubmit the whole tree
   • How Egypt-local Module 1 expectations sit alongside the ICH structure
2. What eCTD means in practice · ~20 min
   • An eCTD is a lifecycle of XML plus files, where the sequence history is as much the product as the documents
   • Sequences replace, append, or delete leaves, and knowing which one you need is most of the skill
   • Enough grounding to brief a publisher and review their output, without operating the publishing tool yourself
3. Egypt next to a GCC or EU pack · ~15 min
   • The ICH spine is shared, while Module 1 and the local letters differ by authority
   • Why an SFDA or EMA timeline is the wrong reference for an EDA clock, and what to use instead
   • How registration work runs alongside pharmacovigilance rather than separately from it