Develop the skills you will need to progress into the electronic age for medicines registration.

2-day training program.

Small focused groups.

One tutor to a maximum of 4 delegates.

Comprehensive electronic environment provided for hands on experience.

This software independent training uses a variety of software tools and will cover the following:

  • Reviewing standards and regulations involved in eCTD and submissions;
  • Setting up the electronic document environment necessary for eCTD;
  • Meeting ZA specific and ICH requirements for the electronic dossier;
  • Keeping control of electronic documents and dossiers for the life cycle of the product;
  • Hands on:
    • Creation of a ZA eCTD from an international CTD supplied as electronic documents.
    • Authoring and Working with electronic documents and ensuring compliance for eCTD submission.
    • Applying the South African Validation criteria. Technical Validation and problem solving.