Useful Advices - Business

Conflicts are inevitable, but the more we know about human nature, the more positive the outcome of a conflict might be

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

for both parties. We know that different people have different priorities and different ways of dealing with situations

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

Examples of combination products may in

that may occur, but in general, human beings have certain characteristics that are very similar – even across gender, r

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

cial, and socio-economic lines.

· People love to be agreed with.
· People hate to be disagreed with.
· People

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

like other people who agree with them.
· People dislike other people who disagree with them.
· People who are

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

Combination pro

good at resolving conflicts look for some point of agreement and use good people skills to get others to see a different

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

point of view.

So if we know that when we disagree with people, we are likely to raise resentment, it might be a good

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

dea to strengthen our soft-skills – our people skills – when dealing with conflicts or potential conflicts. If we find

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

ourselves in a tense situation, and we raise our voice, the other party is likely to respond in kind. This will usually

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

escalate the situation quickly. Instead, below are SEVEN tips for avoiding and ultimately resolving conflicts.

1. B

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

e proactive instead of reactive. Good plans shape good decisions. That's why good planning helps to make elusive dr

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

Following aspects would a

eams come true. –Lester R. Bittel

2. Be slow to anger—especially over petty issues. Anger is always more harmful

dd to the challenges in developing combination products:

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

than the insult that caused it. –Chinese Proverb

3. Instead of telling people they are wrong, point out mistakes in

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

directly. A person convinced against his will is of the same opinion still. –Samuel Butler

4. Look for some typ

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

of common ground as soon as possible. A compromise is the art of dividing a cake in such a way that everyone belie

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

ves he has the biggest piece. -Ludwig Erhard

5. If you find that you are in the wrong, admit it. It’s easier to

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

Professional from academic institutions, pharmaceutical industries, health care indust

eat crow while it is still warm. –Dan Heist

6. Admit one of your own poor decisions before pointing out a similar er

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

ror by others. A man should never be ashamed to own he has been in the wrong, which is but saying... that he is wis

.

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

r today than he was yesterday. -Alexander Pope, from Miscellanies by Jonathan Swift

7. Mend fences whenever possibl

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

Companies that provide selfless information through particip

e. Never does the human soul appear so strong as when it forgoes revenge, and dares forgive an injury. -E.H. Chapi

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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