Main Subject - Business

Effective leaders are known for being excellent communicators. Here's what to do.

1) Avoid "Not." Negative talk enc

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

ourages arguments, counter attacks, and attempts to solve your problems. It also creates a negative impression. Fo

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

Examples of combination products may in

r example, when you say, "I can't," you appear helpless and ineffective. Instead, talk about what you can do and

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

what you want.

2) Deal with impossible requests by 1) acknowledging the request, 2) empathizing with the other per

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

son's feelings, 3) saying, "I wish I could fix it." and 4) suggesting a reasonable alternative." For example, imag

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

Combination pro

ne that you work at a resort and it is raining. A guest walks up to you carrying a golf bag, slams it against your

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

desk, and shouts, "This place stinks! I spent thousands of dollars coming here and it's raining."

You respond

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

by saying, "You're right it's raining. And I know how upsetting it must feel to travel this far and be stuck insid

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

e. I wish I could make it stop. In the meantime, you may want to visit our indoor putting center. Our golf pro is

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

offering instructions this afternoon."

3) Deal with difficult requests by 1) affirming your willingness to help a

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

d 2) asking the other person to help you plan a solution.

For example, if your boss asks you to start another pro

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

Following aspects would a

ject, you could say, "I understand you want me to start a new project. And right now I'm working on another proj

dd to the challenges in developing combination products:

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

ect. To help me set my priorities, I wonder which one you want me to finish first."

4) When possible, offer choic

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

es that show the consequences of different options. This allows the other person to choose both the process and it

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

s impact.

For example, you can say, "That's a great idea. And there are different ways I can meet your request. W

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

can use our existing supplies, which are free, or we can buy custom materials, which will cost $500. Which option

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

Professional from academic institutions, pharmaceutical industries, health care indust

would you prefer?"

5) Deal with complaints by asking the other person to describe a fair settlement. You can say

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

, "What do you want?" or "What would you consider a fair solution to this?" or "What would make you happy?"

6) A

.

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

smile significantly affects how you sound. It also makes you more approachable. When you frown, other people hear

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

Companies that provide selfless information through particip

anxiety, caution, fear, and rejection. A smile (or at least a pleasant expression) encourages open communication

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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