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The Pre-reg out there are nearing the end, and after 7-9 months of combining work and study,

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

are now banished to the books, revising for the Final Assessment. After two degrees and two s

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ets of professional exams, I sympathise thoroughly with you all - we have all been through it

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

Be reassured though. The exams are stressful, and although some people say it’s a myth, most

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

examiners do want you to pass.

I’m sure you have found that the year to date seems very var

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

iable when talking to your friends. Some will have found the quarterly assessments a breeze w

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

th little work involved, whilst others will have been asked a barrage of questions every 3 mo

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nths that appeared never ending and the questions getting exponentially harder. For the Final

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

Assessment though, the playing field is level and my experience is that the examiners are fa

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rly even throughout.

The final assessment is about making sure you are fit to practice. Yes,

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

you are expected to be knowledgeable, but the deepest theories about the hardest subjects sh

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ould have been covered in the quarterly assessments. It is not physically possible in the sho

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

t amount of time for each exam to cover the whole syllabus. So target your revision. Look at

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

the core competencies. These are what are been examined. Can you take a good case history? Ca

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

n you refract accurately? Can you recognise a suspicious optic disc.?

Take each exam as a se

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

arate entity. When that section is completed, forget about it. You cannot change the results.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Thinking about errors will only distract you from the next exam.

Unlike me, hopefully most

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

of you will have been on some kind of revision program or preparation course. These are run m

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

inly by examiners, and give you an accurate guide to the exam style and this inside knowledge

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

is the best armour you can have. After all, they will be sitting the other side of the table

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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