Advice You - Business

Q & A - Is It Necessary?
YES - Absolutely - No Doubt About It!
•Do you run out of time therefore leaving no time for questions?
•Do you

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

have time for questions but not enough time to answer everyone?
•Do you end your presentation with questions?
If you answered yes to any of

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

Examples of combination products may in

these questions (no pun intended) then you need to read this article. The goal of your presentations is to be able to answer "no" to each one.

Why ques

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

ions are important
1.You need to give your audience what they need, but you won't know what they need unless they ask you.
2.Someone may giv

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

you a testimonial or tell you that they agree with everything you are presenting. This helps go get buy-in from the rest of your audience.
3.Give

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

Combination pro

you an opportunity to clear any confusion up or add something you may have forgotten.

How to make time for questions
1.Prepare your entire prese

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

ntation in advance and time it.
2.Know exactly what time you need to end your presentation and then determine what time you need to start the ques

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

ions and answers segment.
3.You can also have questions and answers during your entire presentation, but still allow time towards the end for fina

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

questions. An interactive presentation will keep your audience alert and engaged.

How to handle questions
1.Answer the question to the entire au

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

ience, not just to the person who asked it. Everyone wants to hear the answer. Maybe everyone had the same question. Answer to everyone and you will kee

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

everyone engaged.
2.Do not walk towards the person who asks the question. Something that we do automatically. Stay centered and keep the attentio

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

Following aspects would a

n of your entire audience.
3.Repeat the question to the entire audience. This will help you to clarify the question to make sure you understand wh

dd to the challenges in developing combination products:

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

t the person is asking and it will also prevent someone from saying "WHAT WAS THE QUESTION?"

End Q & A on time
1.In your preparation know exactly

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

how much time you have allowed for questions and what time you need to end.
2.If there are still questions unanswered when your time is up, say so

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

ething like: "I see there are a lot more questions. I will be around for a little while after the meeting so please come up to me afterwards and I'll be

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

happy to answer your questions."
3.Do not end your presentation with Q&A. Even though many do, it's not the way to leave your audience with impact

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Have a strong closing. Remind your audience what you want them to say, think, or feel. This is what they will remember most so make it good.

Here is

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

y closing for this article When handling questions remember to remain in control of the program and of the audience. Don't let your audience throw you

.

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

off track. They are relying on you to stay on track, to move the questions along, and to take charge when necessary.

If people are asking questions, it

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

Companies that provide selfless information through particip

is a good thing. You have created interest in your audience. They want more. Leaving your audience wanting more should be the goal of every presentation

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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