Advice You - Business

A day in the life of a business person can be filled with joy and satisfaction or it can be frustrating and stressful. When things go wrong, some pe

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

ople lose control. Holding emotions in check and reacting professionally under fire are not always easy. It is particularly difficult to be nice to

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

Examples of combination products may in

people who are not being nice to you.

So what do you do to keep your cool when the customer is chewing you out? Most of the time, it is not even y

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

our fault. It could be that the problem was with a product or a service delivered by someone else in your organization. You're getting the blame be

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

cause the unhappy person found you first, and it's not pleasant. When faced with angry people, there are four key steps that will help diffuse the s

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

Combination pro

ituation.

Step one is to apologize. "But," you say, "it's not my fault." It doesn't matter who's to blame; apologize anyway. As a representative

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

of your company you have a responsibility to see that things go well. Your willingness to be accountable will have a positive effect. After all, it

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

takes two to have an argument. If one of you refuses to be disagreeable you can't have a disagreement. You are not accepting blame-you are simply say

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

ing, "I'm sorry about the problem." You are wasting your breath unless you apologize with complete sincerity so be sure that your tone of voice matc

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

hes your words.

Step two is to sympathize with the irate customer. Let the person know that you can identify with his feelings. Say that you under

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

stand the frustration of receiving a faulty product or poor service. The angry person begins to feel better as soon as his reaction is validated.

S

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

Following aspects would a

tep three is to accept responsibility for the situation. Be accountable to the customer. Let him know that you intend to do whatever it takes to ma

dd to the challenges in developing combination products:

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

ke things right. You can't help what has already happened, but you will come up with a solution to the problem or you will find someone who can.

Th

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

e last step is to take action. Decide what you can do and tell the customer. You will replace the defective or incorrect product as quickly as poss

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

ble. If the issue was poor service deliver better service. Whenever you can offer a bonus of some sort or waive fees, the tiger before you is trans

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

formed into a pussycat.

Use the acronym "ASAP" to remember these four steps for calming upset customers. Each letter stands for part of the process

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

Professional from academic institutions, pharmaceutical industries, health care indust

.

A is "apologize."

S represents "sympathize."

A stands for "accept responsibility."

P means "prepare to take action."

Nothing will be solved by

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

becoming argumentative and reactionary. Instead, diffuse the client's anger by being apologetic and sympathetic and focus on positive steps that wi

.

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

ll resolve the situation. Before you know it, your adversaries will become your allies.

Oh yes, remember to smile. It will make everyone feel bett

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

Companies that provide selfless information through particip

er and behave better.

(c) 2005, Lydia Ramsey. All rights in all media reserved. Please reprint article with by-line intact and all links made live

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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Advice You - Keeping Your Cool When The Customer Gets Hot

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