Summary - Relationships

Saying no is difficult for us most of the time but making others understand that you mean it, is even more difficult. S

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

ometimes people keep on insisting until you say yes. But if you resolutely say no the first time they won’t have a chan

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

Examples of combination products may in

ce to try again. In this article you will learn how to say no and mean it.

Try to think of a valid reason for refusing

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

an offer. If you kept coming up with excuses that could be overlooked easily, the other person will never let you go. S

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

ay no determinedly and offer another day to do the activity the other person is proposing. If he/she still insists, the

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

Combination pro

n say ‘Maybe some other time’ and move on with a smile. You have got to learn to say no otherwise people will keep crow

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

ing you with their ideas and eat up most of your precious time.

When somebody asks you to help them out with something

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

, don’t think that just because you have a reputation of being helpful and cooperative among your colleagues and friend

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

s, you have to say yes otherwise it will be ruined. Honestly think about the time you have and that what is being asked

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

of you is really something you want to do. Don’t fall into the trap of someone being innocent of not doing the thing hi

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

mself. Also never offer an apology after rejecting an offer; after all it’s your life and only you know how you want to

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

Following aspects would a

live it. Others are not supposed to decide what you should be doing at a particular time.

Look the other person in th

dd to the challenges in developing combination products:

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

eye when you say no. This way they will be sure of what you’re saying is what you mean rather than just inventing excu

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

ses like everyone else do. Try to keep yourself busy all the time, or at least show that you’re a lot busier than they

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

think you are. If somebody keeps on insisting then straight forwardly tell them your list of chores you have to do for

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

hat day. Don’t let others get hold of your time and energy. Your family comes first and foremost when it comes to givin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g time to others. So tell people that you have family plans today or that you have to take your children out so you are

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

leaving early today.

Don’t let guilt wash over you as you say no to a request. Your relationships will be much better

.

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

and healthier when you know how to deal with difficult situations. Saying no to offers you can’t accept or requests you

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

Companies that provide selfless information through particip

don’t have time to fulfill is just one of those situations. Firmly believe in what you want and let others know it too

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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