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.