Register your pharmaceutical products in Kuwait
Master pharmaceutical products regulatory activities with sate of Kuwait MOH
Teaching & Academics,Other Teaching & Academics
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
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
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
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