Advice Pool - Business

Your impact at meetings will determine in a big way how well you do in your career. In other words you will rise as high as your c

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

ommunication skills will let you. Ability and competence in your position is expected - how well you get your point accross will m

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

Examples of combination products may in

ake the difference between your opinion being valued and your input getting forgotten one more time.

Look at any business leader,

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

politician or community spokesperson. What do they all have in common? The ability to speak in a way that really gets people to li

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

sten even when people may not agree with them. What success tips can you learn from effective communicators that is applicable to

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

Combination pro

our occupation?

1. Prepare in advance for the meeting. Make sure you are up to date with the subject matter and that you have cove

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

red your area of responsibility. Your confidence will grow when you can anticipate what will be discussed. Walking into a meeting

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

unprepared is an invitation for tense moments and anxiety in case someone catches you out. Thorough preparation is essential.

2.

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

Rehearse what you will say. In your mind run through possible scenarios with the people attending the meeting. Picture yourself re

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

laxed, confident and even enjoying yourself as you make your voice heard. See the others listening attentively to what you have to

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

say and valuing your opinion. Make the pictures lifelike with rich color, sound and feelings. I recommend doing this the evening b

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

Following aspects would a

efore the meeting, when you are relaxed, for at least 20 minutes

3. Speak with enthusiasm - lead and people will follow, if you s

dd to the challenges in developing combination products:

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

peak with energy and enthusiasm everyone else will assume that they should be at least interested in what you have to say. If you

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

are not enthusiastic about your work, at least speak with energy by sitting up and speaking with emphasis on key words. Watch poli

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

ticians on T.V. to see how they stress their point.

4. Anticipate objections and be ready with your response. What are the questio

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

ns you really do not want to be asked? Work out the best responses and rehearse how you will take charge of the situation.Then whe

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

Professional from academic institutions, pharmaceutical industries, health care indust

the meeting takes place you will already know what to say and can instead focus on listening to everyone else.

5. Exude certainty

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

. Nobody wants to hear that you are not sure whether you can do something. Be certain about what you can do, and be direct when yo

.

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

u need more information or more resources to get something done. Whenever you hear someone agonising over whether something can be

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

Companies that provide selfless information through particip

done, notice the negative effect it has on those listening, and remind yourself that you will not allow the same to happen to you

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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