Useful Advices - Business

Most people find the act of a goal setting activity almost impossible because th

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

ey set goals that are way too large and become disheartened before they ever com

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

Examples of combination products may in

e close to reaching them. A goal setting activity that works is one that is brok

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

en down until it represents a single event. It is the progressive, sequential ac

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

cumulation of single events that ensure the final desired end result.

For examp

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

Combination pro

le, if your goal setting activity is to save $10,000 this year and you are paid

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

fortnightly, you should have 26 single event goals, each written progressively t

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

o allow for changed circumstances.

Your goal setting activity should be what I

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

call SMARTIES! SMARTIES is an acronym for the following:

SPECIFIC Be absolutel

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

y specific when producing a goal setting activity and use the present tense.

ME

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

ASUREABLE You need to be able to monitor your progress so you can measure your

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

Following aspects would a

success.

ATTAINABLE You also need to be able to conceive your goal to attain i

dd to the challenges in developing combination products:

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

t.

REALALISTIC Obviously goals need to be within the grounds of logic and circ

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

umstance.

TANGIBLE Your goal needs to be something that is real or physical, t

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

hat you can see and/or touch.

INSPIRATIONAL If your goals don’t inspire you it

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

’s unrealistic to expect that you’re going to be driven to achieve them.

EMOTIO

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

Professional from academic institutions, pharmaceutical industries, health care indust

NAL The more emotionally involved you become with your goal the quicker it will

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

manifest into your life.

During your goal setting activity, as well as writing

.

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

down your goals, I recommend you write down every possible benefit you will rea

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

Companies that provide selfless information through particip

lize as a result of achieving your goal and its impact on all areas of your life

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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