Register Healthcare Products Centrally in the GCC By SFDA
Central Registration with GHC
Lectures -17
Resources -8
Duration -4 hours
30-days Money-Back Guarantee
Get your team access to 10000+ top Tutorials Point courses anytime, anywhere.
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
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
Just the PC and enough time , block at least 2 hours
![Register Healthcare Products Centrally in the GCC By SFDA Register Healthcare Products Centrally in the GCC By SFDA](https://d3mxt5v3yxgcsr.cloudfront.net/courses/7644/course_7644_image.jpg)
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](https://www.tutorialspoint.com/assets/profiles/444387/profile/200_4022225-1650364554.jpeg)
Zahra Hassan Sobhy
Course Certificate
Use your certificate to make a career change or to advance in your current career.
![sample Tutorialspoint certificate](/market/public/assets/newDesign/img/primePacks/V-certificate.png)
Our students work
with the Best
![adobe logo](/market/public/assets/newDesign/img/adobe.png)
![adp logo](/market/public/assets/newDesign/img/adp.png)
![apple logo](/market/public/assets/newDesign/img/apple.png)
![armani logo](/market/public/assets/newDesign/img/armani.jpg)
![bosch logo](/market/public/assets/newDesign/img/bosch.png)
![capegemini logo](/market/public/assets/newDesign/img/capegemini.png)
![cisco logo](/market/public/assets/newDesign/img/cisco.png)
![hdfc bank logo](/market/public/assets/newDesign/img/hdfcbank.png)
![ibm logo](/market/public/assets/newDesign/img/ibm.png)
![intel logo](/market/public/assets/newDesign/img/intel.png)
![mastercard logo](/market/public/assets/newDesign/img/mastercard.png)
![netflix logo](/market/public/assets/newDesign/img/netflix.png)
![qualcomm logo](/market/public/assets/newDesign/img/qualcomm.png)
![samsung logo](/market/public/assets/newDesign/img/samsung.png)
![sony logo](/market/public/assets/newDesign/img/sony.png)
![unilever logo](/market/public/assets/newDesign/img/unilever.png)
![walmart logo](/market/public/assets/newDesign/img/walmart.png)
![adobe logo](/market/public/assets/newDesign/img/adobe.png)
![adp logo](/market/public/assets/newDesign/img/adp.png)
![apple logo](/market/public/assets/newDesign/img/apple.png)
![armani logo](/market/public/assets/newDesign/img/armani.jpg)
![bosch logo](/market/public/assets/newDesign/img/bosch.png)
![capegemini logo](/market/public/assets/newDesign/img/capegemini.png)
![cisco logo](/market/public/assets/newDesign/img/cisco.png)
![hdfcbank logo](/market/public/assets/newDesign/img/hdfcbank.png)
![ibm logo](/market/public/assets/newDesign/img/ibm.png)
![intel logo](/market/public/assets/newDesign/img/intel.png)
![mastercard logo](/market/public/assets/newDesign/img/mastercard.png)
![netflix logo](/market/public/assets/newDesign/img/netflix.png)
![qualcomm logo](/market/public/assets/newDesign/img/qualcomm.png)
![samsung logo](/market/public/assets/newDesign/img/samsung.png)
![sony logo](/market/public/assets/newDesign/img/sony.png)
![unilever logo](/market/public/assets/newDesign/img/unilever.png)
![walmart logo](/market/public/assets/newDesign/img/walmart.png)
Related Video Courses
View MoreAnnual Membership
Become a valued member of Tutorials Point and enjoy unlimited access to our vast library of top-rated Video Courses
Subscribe now![Annual Membership Annual Membership](/market/public/assets/newDesign/img/membership-large-small.jpg)
Online Certifications
Master prominent technologies at full length and become a valued certified professional.
Explore Now![Online Certifications Online Certifications](/market/public/assets/newDesign/img/traning-for-a-team.png)