Master Pharmaceutical products registration In Egypt Course

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About Course

Learn how to confidently register pharmaceutical products in Egypt through this practical, industry-focused course covering the complete Egyptian pharmaceutical registration process.

This course provides a step-by-step guide to navigating the requirements of the Egyptian Drug Authority and the Egyptian Ministry of Health, including NODCAR analysis, pricing strategy, dossier preparation, pharmacovigilance, renewals, and regulatory exceptions.

Designed for Regulatory Affairs professionals, pharmaceutical companies, importers, manufacturers, and healthcare business leaders, this course simplifies complex Egyptian regulations into a clear, practical, and easy-to-follow learning experience.

What Will You Learn?

  • By the end of this course, you will:
  • Introduction to the Egyptian Drug Authority and Egyptian pharmaceutical regulatory framework
  • Understanding the complete pharmaceutical product registration process in Egypt
  • Preparing and managing registration dossiers and submission requirements
  • Conducting NODCAR analysis and understanding market positioning strategies
  • Understanding pharmaceutical pricing systems and pricing submission strategies
  • Managing pharmacovigilance requirements and post-marketing compliance
  • Handling renewals, variations, and lifecycle management activities
  • Understanding market exceptions, special pathways, and regulatory updates
  • Best practices for achieving successful market access in Egypt
  • Navigate into the update guidelines of EDA.

Course Content

Module 1: Introduction To Pharmaceutical Products Registration In Egypt
Let's get introduced and master EDA

  • Introduction
    12:06

Module 2:Pricing
In this section we will be exposed to the details of the price form, which is so crucial for box opening

Module 3: The Submission Dossier
In this section we will practice the actual dossier submission

Module 4: NODCAR
In this section we will move to the NODCAR with our registration samples to perform the analysis there , till we grant our registration certificate

Module 5: Tracking /Tracing
In this section we will have a look on some updated circulars of the tracking and tracing

Module 6: PV Documents
In this section we will go through the details of the second crucial documents for the box opening for pharmaceuticals,m which is the PV documents and its options.

Module 7: Variations
In this section we will dive deeper to the variations , case by case

Module 8: Variation Guidelines
In this section we will complete our variation guidelines

Module 9: Variations Final section
In this closing session with ill finalise our variation guidelines and end up our journey with MOH of Egypt for pharmaceuticals

Module 10: Updated Pharmaceutical products submission with EDA
You will master the updated pharmaceutical products submission with EDA, from CTD to eCTD,

Module 11: Synthetic Peptide Human Registration with EDA
Synthetic Peptide Human Registration with EDA

Module 12: The updates of GDSP, eCTD, GTIN
Master the updates of GDSP, eCTD, and GTIN implementation

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