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MANAGING SMALL MEETINGS: Keep the size of the meeting as small as p

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

ossible. The larger the group, the more complicated communication b

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

Examples of combination products may in

comes and the more garbled the purpose may get. For example, with a

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

group of two, there are two communication channels, add a third per

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

son and six channels have been created. With each additional person

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

Combination pro

the number of communication channels increases exponentially. When

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

selecting participants for the meeting, consider the following crit

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

eria: -- expertise in the topics -- contribution to the discussion

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

- pre-existing personal conflicts -need for new information.

MANAG

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

NG MEETINGS: Select a time to meet when participants are most likel

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

to be punctual and attentive. The most productive time is generall

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

Following aspects would a

y early morning, after employees have had a chance to drink their m

dd to the challenges in developing combination products:

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

rning coffee. The least productive time is usually right after lunc

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

or towards the end of the day when other work remains unfinished.

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

MANAGING MEETINGS--LENGTH: Set a specific time limit on meetings,

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

deally a maximum of 1 ? hours. Get into the habit of starting the m

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

Professional from academic institutions, pharmaceutical industries, health care indust

eting on time, regardless of attendance. If you wait for late comer

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

s, you penalize present attendees, and encourage tardiness. Adjourn

.

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

the meeting at the appointed time, even if all items on the agenda

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

Companies that provide selfless information through particip

ave not been completed. You can always reconvene at some other time

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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