Digg It - Business

The disagreement between people is inevitable however if it's not resolved it can lead to

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

a complete breakdown in communication. You need to accept that the issues the other person

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

Examples of combination products may in

has are real to them no matter how far from reality you think it is. You also need to bot

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

h take away any personal aggression and avoid personal attacks as this will lead to failur

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

e to resolve things.

Below are a few suggestions that can help you resolve issues:-

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

Combination pro

ong>1. Arrange a Neutral meeting place - If at all possible arrange the meeting i

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

n a mutually agreed location away from your office and indeed theirs. This will help to ge

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

erate a balanced meeting. Ensure that you will not be disturbed and agree a time frame for

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

discussion.

2. Use a facilitator/arbitrator - It may be useful to use/

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

employ a facilitator when the problem seems to be irreconcilable without one. In which cas

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

e ensure you use somebody who sets clear guidelines and gains your agreement that you are

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

Following aspects would a

both committed to making this work.

2. Mutual respect – As you begin the

dd to the challenges in developing combination products:

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

meeting you must respect both yourself and the person you are having difficulties with. I

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

t is the problem that you want to resolve to allow you to work/be friendly with each other

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

in the future.

2. Legitimate disagreement – You must accept disagreement

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

as natural and inevitable and even potentially acknowledge the fact that disagreement can

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

Professional from academic institutions, pharmaceutical industries, health care indust

be positive to reach an improved solution to a situation.

3. Form a contract – <

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

/strong>You must contract to work on the issue for mutual resolution and mutual benefit.

.

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

Resolving disagreement is a scenario that needs a win-win resolution. Without this, one pa

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

Companies that provide selfless information through particip

rty will invariably walk away disgruntled and this could effect future business situations

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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