Master pharmaceutical products Registration Kuwait

Master pharmaceutical products Registration Kuwait free download

Master pharmaceutical products regulatory activities with sate of Kuwait MOH

In this course, we will explore together how we can place our pharmaceutical products in the highly potential market of Kuwait, a relatively small market driven by tenders.

What will you learn?

• Introduction to Kuwait MOH

• Site Registration

• Product Registration

• Stability

• Renewal

• Cancellation

• CTD

• M1

• M2

• M3 Quality

• MOH circulars

• Ministerial decrees

• CTD structure as per M1 guidelines The

• Finished product

• Variation

• PV Updates

We will be the experts on 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, and straight to the point.

MOH of the state of Kuwait does not have any electronic system for handling regulatory activities and has not yet adopted the eCTD system. That is why the state of Kuwait of MOH considers 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, and 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 on a 2 2-hour flight we will return from this flight as experts in pharmaceutical products registered with the state of Kuwait.

So let's take off.