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MANAGING MEETINGS--BEING PREPARED MAKES A DIFFERENCE: You can schedule all th

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

e meetings you want to, and if you are not prepared to take charge then you’r

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

Examples of combination products may in

wasting your time. The time you invest planning a meeting is time well spent

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

The sooner you take action, the sooner you can enjoy the fruit of a producti

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

e meeting. Before you schedule a meeting, determine its purpose and necessity

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

Combination pro

Document specifically what you expect to accomplish during the meeting (incl

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

uding goals and objectives). A clearly written plan allows you to focus solel

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

on the issues you need to address. Next, determine whether this purpose can

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

e more efficiently achieved by some other means, such as a phone call, a writ

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

en memo, or an informal conversation.

MANAGING MEETINGS--AGENDA: At least on

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

week before a meeting, develop the agenda and send it to expected participan

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

Following aspects would a

ts. The agenda should clearly indicate: 1. the meeting’s starting and ending

dd to the challenges in developing combination products:

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

ime, 2. location of the meeting, 3. items (goals) to be covered and desired o

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

tcomes (objectives), 4. items listed in priority order, 5. time planned and s

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

heduled for each item, 6. preparation expected of participants, and 7. the pe

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

son responsible for presenting each item.

SETTING YOUR AGENDA: People usuall

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

Professional from academic institutions, pharmaceutical industries, health care indust

y plan an agenda backwards, placing the most important item last and the mino

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

items first. However, you should plan the agenda the opposite way, by placin

.

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 most important item on the agenda first and the least important items la

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

Companies that provide selfless information through particip

t. This way, if you run out of time, you will have covered the crucial topics

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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