Main Subject - Business

Effective questioning is a powerful and often underused skill in negotiation. Asking questions h

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

as many benefits.

1. It gives you a better chance of answering the brief effectively.

2. It sh

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

Examples of combination products may in

ws the client you care about their business.

3. The information you acquire and the way in whic

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 you interpret the information can really help you establish how interested the client is in bu

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

ing from you.

4.It helps to establish rapport.

It is also a natural progression to listening.

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

Combination pro

If you have truly listened and not re-loaded there may be a silence for a while. Initially this

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

ay seem like an eternity but you will get used to that and will become quicker to respond.

With

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

all the information on board you can now make good sound judgements based on what was said and

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

ot said.

There are two types of questions that are regularly used in negotiation – open and clo

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

sed. When you are in fact-finding stage you use many more open questions. They are ones that req

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

ire a lengthy answer and are difficult for your client to just to say yes or no.

Open questions

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

Following aspects would a

are inquisitive, showing interest in them and what they want. They use opening words such as wha

dd to the challenges in developing combination products:

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

t, who, why, how, where and when. Closed questions tend to open with was, were, are, could, did

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

nd is. It is amazing how one or a few words can change a question from open to closed.

For exam

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

ple:

Closed - Can I help?

Open - How can I help?

Also never assume that you know something. F

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

r example you may assume that they are not happy with price because they have not really wanted

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

Professional from academic institutions, pharmaceutical industries, health care indust

to commit to anything. Unless you ask questions you cannot know. You may want to ask a specific

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

closed question to pin them down.

i.e. Is there anything I can do to help you decide to use us?

.

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

So much is down to interpretation and as we all channel information in and out in different wa

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

Companies that provide selfless information through particip

s you need to clarify things.

Remember the adage - never assume it makes an ASS out of U and ME

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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