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Register your pharmaceutical products in Kuwait

person icon Zahra Hassan Sobhy

Register your pharmaceutical products in Kuwait

Master pharmaceutical products regulatory activities with sate of Kuwait MOH

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Teaching & Academics,Other Teaching & Academics

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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

What will you learn in this course:

  • By the end of this course you will master Pharmaceutical products registration in Kuwait

Prerequisites

What are the prerequisites for this course?

  • Just laptop and willing to succeed

Register your pharmaceutical products in Kuwait

Curriculum

Check out the detailed breakdown of what’s inside the course

Introduction
1 Lectures
  • play icon Introduction 08:45 08:45
Site Registration
1 Lectures
Tutorialspoint
Product registration
1 Lectures
Tutorialspoint
Stability
1 Lectures
Tutorialspoint
Renewal/Cancellation
1 Lectures
Tutorialspoint
CTD
1 Lectures
Tutorialspoint
Module 1
1 Lectures
Tutorialspoint
Module 2
1 Lectures
Tutorialspoint
Module 3 "Quality"
1 Lectures
Tutorialspoint
MOH Circulars
1 Lectures
Tutorialspoint
The Ministerial Decree
1 Lectures
Tutorialspoint
CTD Structure as per GCC Guidelines M1
1 Lectures
Tutorialspoint
CTD Structure as per GCC Guidelines M2
1 Lectures
Tutorialspoint
The Finished Product
1 Lectures
Tutorialspoint
The Renewal
1 Lectures
Tutorialspoint
Variations
1 Lectures
Tutorialspoint
Finished Products variations
1 Lectures
Tutorialspoint
Pharmacovigilance
1 Lectures
Tutorialspoint
The Updates
1 Lectures
Tutorialspoint

Instructor Details

Zahra Hassan Sobhy

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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