Master the updates of medical devices registration with KSA
SFDA changed the regulatory pathway of medical devices from GHTF to Technical file submission
Updated on Oct, 2023
Language - English
Lectures -6
Resources -4
Duration -1.5 hours
Course Description
In this course, we will explore together the latest updates of SFDA, the health authority of the KSA the leader of the GCC countries, and the whole META region.
The SFDA has changed the regulatory pathway of medical devices registration from the GHTF "Global Harmonization Task Force" which is the global organization responsible for handling the registration of medical devices with global standards
and requirements for the dossier submission.
SFDA adopted the Technical File submission regulatory pathway of medical devices, which is closer to pharmaceutical products, the checklist went longer with a high emphasis on the quality, and safety of the medical devices, as per the general trend of most of the health care authorities in the META region, that the pharmacovigilance activities which is handling the safety of the products are highly involved , not only during the first time submission of the dossier but also during the renewal and variations as well.
These updates started in 2020, passed by transition stage within 2021 to be Inforced in January 2022
So let us master the updates of the leader of the region
As those update's are expected to be enforced by other GCC countries in a matter of months
Let's face the challenge of the regulatory affairs profession , which is keeping up with the updates
So let's start our interesting journey with SFDA
See on board
Who this course is for:
- All levels of Pharma student , fresh graduates, and Pharma industry professionals
Goals
What will you learn in this course:
- Master the latest updates of medical devices registration with SFDA
- SFDA changed the regulatory pathway of medical devices from GHTF to Technical file submission
- Keep up to date with latest regulations of medical devices in KSA
- Place your medical devices in KSA market through the new system of technical file submission
Prerequisites
What are the prerequisites for this course?
Just laptop and willing to learn to stand out of the crowd
Curriculum
Check out the detailed breakdown of what’s inside the course
Introduction
1 Lectures
-
Introduction
14:24
14:24
Technical File Assessment Overview
1 Lectures
Technical File Assessment checklist
1 Lectures
Technical File Submission
1 Lectures
The Annexes
1 Lectures
Closing Technical File Submission
1 Lectures
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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