Advice You - Business

Now that you have cleared the written CAT and have received interview cal

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

ls, most of you may be wondering what is the smartest way of CAT GD/PI

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

Examples of combination products may in

reparation. Always remember that at this stage the competition is tougher

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

as the chaff has been separated from the wheat, so you can't afford to

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

e lax.

Here are 3 tips that will aid you in the CAT GD/PI preparation:

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

Combination pro

) Keep it simple: You cannot remember each and everything about the econo

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

y, trying to do so will make you feel overwhelmed and under prepared. A

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

ways pick an issue and choose the 3 most important aspects of that issue

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

nd prepare that. For example suppose you are reading about the Growth i

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

Indian aviation sector. Pick issues such as (a) The need for mergers (2)

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

Allowing domestic airways to fly international routes (3) Need for upgrad

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

Following aspects would a

ation of airport facilities. Sticking to just 3 issues gives focus and

dd to the challenges in developing combination products:

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

confidence

2) Become a rainmaker: Try to come up with possible solutions

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

If you go to the IIM Group Discussion and Personal Interview and the top

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

c was "Infrastructure in Mumbai" and all you did was crib about how bad

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

it is. Then guess what - you're out. You are supposed to think how to imp

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

Professional from academic institutions, pharmaceutical industries, health care indust

ove, leave the cribbing to your 75 year old uncle across the street.

3)

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

he 2 minute approach: You are not there to read an essay, no one will giv

.

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

you that much time. Whatever points you have prepared - time them to f

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

Companies that provide selfless information through particip

nish in 2 minutes or less with all the important points well said in time

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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