Master Pharmaceuticals registration KSA

person icon Zahra Hassan Sobhy

Master Pharmaceuticals registration KSA

Master pharmaceutical products registration, in the biggest and most important market in the GCC region.

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Teaching & Academics,Pharmaceutical Indutry


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Course Description

This course will provide you with all the required knowledge, skills, in addition to the experience from practice to master pharmaceutical products in the biggest and most important market ever in the GCC region, the market that could not be missed by any pharmaceutical or healthcare company seeking for a considerable ROI, and achieving the required revenue

By the end of this course, you will be the expert on pharmaceutical products registration, renewal, and variations

We will start our journey towards the market of Sudi Arabia by the classification, focusing on the specific situations to classification mismatch between COO and SFDA of Sudi Arabia, these cases which became too many over the past 5 years, not like before, not like other health authorities which usually follow the COO classification.

and this topic of classification is so critical, so in this course, you will learn from practice how to proceed with these quite common cases.

Then we will go together to the eSDR system to see how the workflow of the pharmaceuticals registration process

Exploring the eCTD, structure, modules, and checklist of each module, how to prepare the forms and templates that should be there in each module, keep emphasizing again that module 1 is not part of any eCTD, and how to prepare module 1 that specific for SFDA submission in the KSA.

Then we will explore what is new in these regulations of the SFDA submission, and the drug application process itself.

Afterward, we will explain 2 very specific registration pathways, the Abridged and Verification pathways, each of them will provide a shortcut pathway for the registration, so we will explore these together, these 2 pathways are from practice.

The SMPC and PIL are explained in this course in detail as per the latest versions, templates, and SFDA layouts which are acceptable in all other GCC countries as well, we will learn together how to prepare these SFDA approved layouts.

Then we will go through fast flight to the registration fees, and finally have a look at the final registration certificate, then how to keep it by renewal and variations if any, when and how to prepare for each of them. 

Then we will move to the next step of the tracking /tracing system, and see the shift from the linear barcode to the 2DMatrix barcode, in addition to the new system set by the SFD for the Aggregation, the most updated topic ever, which soon will be applicable in other GCC regions as well, actually, the UAE started with it directly after the KSA.

We gonna end this interesting journey in the KSA by the clearance system of the SFD "IBRCS" and the PV requirements.

So let us start our journey towards mastering pharmaceutical products in KSA market my dear future pharma industry professionals and managers.

Let us strat our sucess story.


What will you learn in this course:

  • You will master the pharmaceutical products registration in the one of the biggest and most important market in the GCC region, in KSA market.

  • Pharmaceuticals registration in KSA

  • Pharmaceutical Products repatriation in KSA

  • Master pharmaceuticals registration in KS A

  • Put your pharmaceuticals product in KSA market, the huge market that brings you most of the GCC region Revenue


What are the prerequisites for this course?

  • Just laptop and willing to succeed

Master Pharmaceuticals registration KSA


Check out the detailed breakdown of what’s inside the course

Master Pharmaceuticals registration KSA
13 Lectures
  • play icon Introduction 05:09 05:09
  • play icon Classification Guide 14:19 14:19
  • play icon Guidelines for pharmaceutical Registration 21:21 21:21
  • play icon ECTD 14:01 14:01
  • play icon ECTD M2-M5 11:44 11:44
  • play icon Application Process 11:06 11:06
  • play icon The Templates 12:15 12:15
  • play icon The CPP 09:05 09:05
  • play icon Special Approaches for Registration 04:03 04:03
  • play icon SMPCS 03:59 03:59
  • play icon Registration Fees 09:51 09:51
  • play icon Tracking/Tracing System 14:05 14:05
  • play icon Clearance 11:07 11:07

Instructor Details

Zahra Hassan Sobhy

Zahra Hassan Sobhy

This is Zahra Hassan, I'm a pharmacist, with almost 10 years of experience in the pharma industry, my experience is extended to cover the regulatory affairs field, which deals with registration and granting health authorities approval for health products, including medicines, medical devices, over the counter products "OTC", such as food supplements, and cosmetics as well.

This is in addition to the quality compliance, control, and assurance for these health products, and also ensuring product safety through pharmacovigilance activities.

I have been practicing all these professions for 10 years covering 20 countries, across the regions of the Middle East, Africa, Levant, and Turkey.

During my career journey, I gave myself lots of credits by postgraduates studies

Msc of pharmacovigilance Bordeaux university France

MBA, Chiffley buisneiss school , Australia

Dual Diploma of regulatory affairs "pharmaceutical and medical devices" RAP society, USA.

Certified lead auditor

currently enrolled in the Ph.D. program of pharmacovigilance Bordeaux university France

Despite the fact that postgraduate studies for sure will add to the profile, but the practice is something else, in the begging of my career journey I was chasing professionals asking for private lessons after work to gain practical experience from them, and it was not for free, I used to make this deal with many professionals as I can to get as much diverse experience that I can gain, in addition, I used to follow national and international pharma industry events attending, then participating from my own pocket. This simply happens when you follow your passion.

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