Digg It - Business

What?

The good…the bad…and the ugly! That pretty much sums things up on the to

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

pic of meetings. There are good ones, bad ones and ugly ones.

So What?

Stop going 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

bad or ugly meetings. Stop conducting bad or ugly meetings. Meetings are often necessary, so if you mu

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

t have one, make it a productive use of everyone’s time.

Now What?

Here are a few qu

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

ick tips to help get your meetings going in the right direction.

Clarify and clearly communica

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

Combination pro

e the purpose of your meeting. The more you clarify, the more you increase your chances of having a suc

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

cessful meeting.

After you clarify your purpose, try to find any legitimate reason to avoid having

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

the meeting. Can things be handled in a memo or an e-mail? Would one-on-one conversations be as or mor

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

effective?

Are the right people invited to your meeting? Are people included that don’t need to b

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

e there?

Can materials be sent to attendees prior to the meeting to facilitate discussions or deci

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

ions?

Be ruthless about starting and ending on time.

Do not allow off-topic discussions. Use

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

Following aspects would a

a flipchart or pad of paper to capture these items and handle them later. Get back on the topic of the

dd to the challenges in developing combination products:

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

meeting as soon as you capture these off-topic ideas.

Have one person designated as a recorder to

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

ake notes for everyone and distribute the notes to all meeting attendees. Everyone except the recorder

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

needs to listen and stay mentally engaged in the meeting.

Establish a clear plan for what happens

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

ext for any follow-up items. Who will do it? What will they do? When will they do it?

To learn mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

re about conducting effective meetings read Death by Meeting by Patrick M. Lencioni and How t

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

o Make Meetings Work by Michael Doyle and David Straus.

Meetings are prime candidates for

.

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

he list of massive time-wasting activities. Don’t look for ways to justify them, look for ways to justi

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

Companies that provide selfless information through particip

fy not having them. If you genuinely can’t figure out a way to avoid a meeting…have a good one.

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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Digg It - Meetings - The Good, The Bad, and The Ugly!

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