Register Healthcare Products Centrally in the GCC By SFDA
Central Registration with GHC
Updated on Sep, 2023
Language - English
Course Description
Central registration, the most updated ever pharma industry interesting topic. The topic which has been always on the table for discussion, many time ago till it has been enforced finally in 2021.
The central registration through the Gulf Health Council "GHC" for pharmaceutical products so far, and very soon will be applicable also to the medical devices.
As regulatory affairs professional you must keep up to date with the changing regulations especially in the META region
The central registration option allows you to make only one single submission, one single dossier for your product, that will be approved in all other GCC countries, so going central, means going to the whole GCC region by only one submission.
Still, you have to submit t individually to each country, but t is just admin work, and the dossier has already been revised and proved by the Gulf Health Council, so it takes 2 months instead of 1 year, that sounds great? for sure
However, soon you will not have to submit individually anymore after central registration submission
Central registration is mandatory for the pharma industry business as it is not allowed to apply for the tenders in the GCC region unless you have central registration, those tenders cannot be missed for any company to achieve the potential ROI.
In this course, we will cover everything related to the topic of the central registration
Staring by Gulf Central Committee For Drug Registration, Human drugs Centralized Registration Process, Module 3 insights, Company (Site/MAH) Centralized Registration, GCC Guidelines for Renewal of Marketing Authorizations, GCC Guidelines for Variation Requirements, GCC Guidelines for Variation Requirements, GCC Guidelines for Presenting the SPC, PIL and Labeling Information, GCC Guidelines for Stability Testing of Active Pharmaceutical Ingredients ( API) and Finished Products ( FPS), GCC Guidelines for the Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products, and finally the central site audit.
Let us master central registration together.
Who this course is for:
- Pharma industry regulatory affairs populations, either fresh graduates or professionals looking for career development, or those who would consider to start their own business as freelancers or outsourcing
Goals
What will you learn in this course:
You will master central registration of pharmaceutical products to the whole Gulf region By only one dossier for one single submission
Central registration of pharmaceutical products to the whole gulf by only one dossier
Central registration of pharmaceutical products through SFDA
Central registration of pharmaceutical products through Saudi Arabia to the whole gulf region
Only one dossier submission per pharmaceutical product to the whole gulf region
Only one dossier submission per pharmaceutical product to be approved in the whole gulf region
Prerequisites
What are the prerequisites for this course?
Just the PC and enough time , block at least 2 hours
Curriculum
Check out the detailed breakdown of what’s inside the course
Central Registration with GHC, SFDA
17 Lectures
-
Introduction
12:26
12:26
-
The Central Registration Process
02:13
02:13
-
Regulatory Aspects of the GCC Countries
10:15
10:15
-
Module 1 in Detail
15:42
15:42
-
Module 2 in Detail
04:16
04:16
-
Module 3 in Detail
10:40
10:40
-
Module 4 and 5
11:27
11:27
-
Module 3 Insights
14:12
14:12
-
Site Submission
14:10
14:10
-
Central Renewal of Marketing Authorisation
25:03
25:03
-
Central variations
15:20
15:20
-
Central variations List 1
39:31
39:31
-
Central variations List 2
03:09
03:09
-
Central SMPC/ PIL
16:02
16:02
-
Central SMPC
08:18
08:18
-
Stability testing for central Registration
22:43
22:43
-
Storage/Transportation for central registration
15:37
15:37
Instructor Details
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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