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When a conversation is not working out there is the potential for massive frustration or a breakthrough depending on how you look a

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

t it.

1. Question your assumptions about the other person

Perhaps the breakdown in communication is based on rumors that have no

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

Examples of combination products may in

basis in reality. You may be unfairly judging the other person and filtering every word he speaks because of a false image of who h

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

e really is.

Have you ever harshly judged someone and found out later you were completely in the wrong? Make sure you are not maki

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

ng the same mistake again.

2. Ask for clarification

Ask the other person to fill in the gaps that are causing you to lose your gr

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

Combination pro

sp on the train of thought.

Asking questions demonstrates your interest in a positive outcome and is to be encouraged. Never worry

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

about looking stupid for asking for more information. The smartest people value information and are always ready to ask for more.

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

3. Are you really listening?

Check that you are really paying attention and not just pretending to be. Change your posture, pay c

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

lose attention to how the other person is talking and demand more of yourself.

Become more attentive simply by choosing to be.

4.

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

Address the issue directly

Be direct and say aloud that you feel the conversation is not working out. Often the other person will

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

agree and together the two of you will be able to work to correct the situation.

Two minds are better than one!

5. Ask for help

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

Following aspects would a

If you often have trouble conversing with a particular person get advice from someone that knows the other person. Very often by do

dd to the challenges in developing combination products:

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

ing this you will get new insights you can act on right away.

And someone who is removed from the situation will have the objectiv

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

ity you need to make sense of the chaos you have created.

6. Take a break

Sometimes the timing just is not right. Reschedule the

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

conversation for a later time when you are better prepared, more rested or not as distracted by other issues.

Forcing something to

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

work out when the odds are stacked against you is difficult and often unnecessary. Get back to it later when you are feeling more

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

Professional from academic institutions, pharmaceutical industries, health care indust

apable and you will make better decisions and with less effort.

7. Aim for good not perfect

Sometimes we hold such high standards

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

for ourselves that we can never win. If you demand 100 per cent success at all times you are setting yourself up for constant disa

.

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

ppointment. Do your best and aim to learn and improve from every experience.

Be kinder to yourself and you will be more relaxed in

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

Companies that provide selfless information through particip

all of your dealings with other people. And ironically your performance will improve because you are not being so hard on yourself

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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