Useful Advices - Business

Your words and behavior tell people a lot about you. Exactly what are your words and behaviors indicatin

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

g about you? Human communication and behavior fall into three basic categories:

Passiveness; Aggressiv

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

Examples of combination products may in

eness; Assertiveness.

Passiveness is a reluctance or inability to confidently express what you think an

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

d feel. In the past, our society rewarded women for being passive and men for being aggressive. But as g

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

ender roles change and women voice their concerns openly, this is changing. Men or women can be passive

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

Combination pro

in their approach to communication.

Aggressive communication and behavior, whether direct or indirect,

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

results in a put-down of the other person, making her feel hurt, defensive and humiliated. Aggressive be

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

avior does not take the other person's goals or feelings into account. Only the aggressor's goals are me

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

t. This often generates bitterness and frustration that later returns as resistance and dissension. Thin

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

k of a time when someone used aggressive communication at the expense of another person. How would you f

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

eel about approaching such a person? Aggression intimidates, demeans and degrades another person. Just a

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

Following aspects would a

s in passivity, men or women can be aggressive communicators.

Assertiveness is an alternative to the ex

dd to the challenges in developing combination products:

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

tremes of passiveness and aggressiveness. It is being confident in expressing what you think, feel and b

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

elieve, standing up for your rights while respecting the rights of others. Assertion is rooted in respec

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

: respect for yourself and for the other person. People tend to cooperate when they are approached or ad

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

vised in a way that respects the needs of both parties. Assertive communication frequently allows both p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ersons to get what they want.

Assertive communication is what healthy communication is based on. Relati

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

onship, whether personal or professional, should strive to be good communicators using assertiveness in

.

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

healthy ways.

Sandra L. Brown Psychotherapist & Author www.HowToSpotADangerousMan.com

This article i

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

Companies that provide selfless information through particip

s free to use as long as the article is used as is, the BIO line is left in tack and the URL is included

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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Useful Advices - Three Categories of Communication

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