Common Technical Documents (CTD) Dossier: Requirements, Preparation, and Submission ((US, Europe and Jordan and KSA))

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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
3 days (2 days can be customized)
Course fee
-

Program Description

This is a practical course which focuses on the preparation of data for submission in the CTD Structure and follow-up, the following topics to be covered with this training, include:

  • Relevant Definitions
  • Background
  • CTD Structure and preparation (Modules 1 – 5)
  • CTD Requirements in different regulatory agencies
  • CTD Requirements for different products categories
  • Regional Administrative Information Module (M1) Requirements in details
  • Quality Module (M3) Requirements in details
  • Other CTD Modules Requirements
  • Comparison between the USA, Europe, and Jordan
  • CTD Dossier Submission, renewal, and variation

Target Level

Beginners to intermediates candidates with the following firms

  • Governmental Institutions
  • Pharmaceutical Industry
  • Development Managers and Experts
  • QA and New Manufacturing Managers

Description

Objectives and Expected Results

By completing the course, Participants SHOULD be able to:

  • Identify CTD modules requirements
  • Identify CTD dossier format
  • Compile data, coordinate, prepare, review, and submit baseline CTD dossier
  • Manage multiple agency submissions
  • Track submission processes at different phases
  • Implement time-saving strategies for streamlining Submissions

Others Training Materials

  • Workbook
  • Interactive practical exercises & discussions during the training course

Target group

  • -

    Trainer Languages English/Arabic

Sign up

Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232