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KEEPING MEETINGS PRODUCTIVE: Whether participants approve or disapprove of an idea, they shouldn’t

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

be penalized or given a raise. If you start criticizing people who disapprove, then you’re only mak

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

Examples of combination products may in

ing your meetings less productive. Likewise, if you start handing out raises to everyone who agrees

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

with you. This kind of behavior conditions participants to contributing only to win approval, rathe

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

r than honestly contributing. Participants may focus more on developing ideas that meet approval, r

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

Combination pro

ther than generating their own creative ideas. To promote a free and creative sharing of ideas, the

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

chairperson needs to exercise support of authority. Their role is to encourage participants to exp

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

ess their own ideas freely and fully.

TALKERS AND NON-TALKERS: Nearly every meeting has talkative

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

members and quiet members. A quiet person may have an important contribution, but may feel intimate

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

by the spontaneity of the meeting. Try to get past this by making eye contact with them while aski

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

ng for a response from the group. Acknowledge a response from another member only if the quiet memb

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

Following aspects would a

er gives no response. In effect, this will encourage him/her to answer the question without pinning

dd to the challenges in developing combination products:

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

them down.

KEEPING DOWN THE NOISE: A more difficult problem to rectify is quieting members who try

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

to dominate meetings. Dominating people usually have immediate responses and go into endless detai

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

if given the opportunity, while sometimes getting off the point and sidetracking the meeting. Thes

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

e participants are usually bright and valuable yet they can ruin a meeting if they are not stopped.

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

Professional from academic institutions, pharmaceutical industries, health care indust

You want to manage this person without alienating them. First, when you believe you understand the

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

point being made, close the topic by saying “Thank you, I understand.” Second, avoid making eye con

.

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

act with this person and/or hold up your hand as a casual stop sign. Finally, if all else fails, ta

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

Companies that provide selfless information through particip

pe record the meeting and ask them to listen to the tape recording. This usually solves the problem

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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