Pharmaceutical Products Registration United Arab Emirates
Be the expert of placing pharmaceutical products in the high potential market of the United Arab Emirates, business hub
Updated on Sep, 2023
Language - English
Course Description
This course will prepare you, to be an expert in pharmaceutical products placement in the high potential market of the United Arab Emirates. the business hub of the Middle East region.
This course will provide you, with all tools that you need to run all regulatory activities related to the pharmaceutical products starting from the registration, to place these pharmaceutical products in the high potential diverse market of the UAE, in Dubai, the GCC region business hub.
Then to perform post-market placement activities, such as renewal/Checklist/Application and variations “Major/Minor”
and variations appendices, in addition to pharmacovigilance.
We will take off together to the United Arab Emirates together, starting our journey with the classification, as the basic mandatory step for the regulation of any product ever with any health authority ever. as they do not follow blindly the COO classification.
Goals
What will you learn in this course:
In this course you will master pharmaceutical products registration in the United Arab Emirates, the business hub of the Middle East in "Dubai".
You will manage all regulatory activities related to the Pharmaceutical products in the high potential market of the United Arab Emirates
You will be the expert to register, renew and make variations also to the Pharmaceutical products in the United Arab Emirates
You will place your Pharmaceutical products in the business hub of the Middle Est region , in the United Arab Emirates, in "Dubai"
Prerequisites
What are the prerequisites for this course?
Just laptop and willing to succeed
Curriculum
Check out the detailed breakdown of what’s inside the course
Pharmaceutical Products Registration United Arab Emirates
18 Lectures
-
Introduction
22:13
22:13
-
LOA
06:47
06:47
-
E-CTD
14:00
14:00
-
M1
08:15
08:15
-
MOHAP e-Transformation
12:10
12:10
-
Attachments
11:41
11:41
-
The Renewal
24:22
24:22
-
Actual Applications
14:52
14:52
-
Variations
16:48
16:48
-
The Required Actions
32:12
32:12
-
The Appendices
14:52
14:52
-
Minor Variation
01:07
01:07
-
Types of Variations
12:47
12:47
-
Minor Variation Lists
22:04
22:04
-
Minor Variation List Continue
20:06
20:06
-
Variation Forms
12:13
12:13
-
Tracking & Tracing
23:44
23:44
-
The Updates
07:46
07:46
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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