Register your pharmaceutical products in Kuwait
Master pharmaceutical products regulatory activities with state of Kuwait MOH
Teaching and Academics ,Science,Pharmaceutical Industry
Lectures -19
Resources -26
Duration -4 hours
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Course Description
In this course, we will explore together how can we place our pharmaceutical products in the highly potential market of the state of Kuwait, such a relatively small market driven by tenders.
We will be the expert of pharmaceutical products registered with the MOH of Kuwait
This journey is so unique compared to other regulatory journeys of other countries, as it is so simple, straight to the point.
MOH of the state of Kuwait does not have any electronic system of handling regulatory activities, not yer adopted the eCTD system. that is why the state of Kuwait of MOH consider only hard copies, and actual physical dossier to be submitted personally through your local agent in Kuwait with Kuwait MOH through prior appointment.
In this short course, we will cover, the whole life cycle of pharmaceuticals starting from classification, passing by registration checklist, then the registration guidelines, and see how we can prepare these required documents, forms, let's practice the actual dossier preparation, then we will move to renewal, we will close the pharmaceuticals registration session with the general conditions as a sum-up, then we will end our journey we will dive deeply into the stability requirements, with great focus on highly demanding, most updated circulars of the pharmacovigilance and its wake up call which is not limited to the state of Kuwait only but also to all other GCC countries.
So fasten your seat belt for this short joyful trip
that we will land in Kuwait for 2 hours flight that we will return from this flight as experts of pharmaceutical products registered with the state of Kuwait.
So let's take off.
Who this course is for:
- All Pharma industry professionals, regulatory affairs professionals, and those who deiced to start their career in the pharma industry
Goals
By the end of this course you will master Pharmaceutical products registration in Kuwait
Prerequisites
Just laptop and willing to succeed
Curriculum
Check out the detailed breakdown of what’s inside the course
Introduction
1 Lectures
-
Introduction 08:45 08:45
Site Registration
1 Lectures
Product registration
1 Lectures
Stability
1 Lectures
Renewal/Cancellation
1 Lectures
CTD
1 Lectures
Module 1
1 Lectures
Module 2
1 Lectures
Module 3 "Quality"
1 Lectures
MOH Circulars
1 Lectures
The Ministerial Decree
1 Lectures
CTD Structure as per GCC Guidelines M1
1 Lectures
CTD Structure as per GCC Guidelines M2
1 Lectures
The Finished Product
1 Lectures
The Renewal
1 Lectures
Variations
1 Lectures
Finished Products variations
1 Lectures
Pharmacovigilance
1 Lectures
The Updates
1 Lectures
Instructor Details
Zahra Hassan Sobhy
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 through postgraduate 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 at Bordeaux University France
Even though postgraduate studies for sure will certainly add to the profile, the practice is something else, At the beginning 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 pocket. This simply happens when you follow your passion.
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