Main Subject - Business

Before you call your next meeting, the FIRST step is to decide if it is reall

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

y essential. To determine that, ask yourself the following:

· Is this meeti

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

Examples of combination products may in

ng essential?
· Can we do without it?
· Can we accomplish the task

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

without a meeting?
· Can it wait another week?
· Can we get things

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

done with few meetings?

Then, if you have decided a meeting is the best way

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

Combination pro

to accomplish your objective, the following tips can help you conduct more ef

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

fective meetings:

1. Start and end meetings on time. Make sure everyone kn

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

ows what time you are to start and to end. If you have an ending time, you w

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

ill find your time is more productive in the time allotted.

2. Have an open

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

agenda on the chalkboard or flipchart. Participants can add an item before

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

he meeting. However, they must be prepared to lead the discussion if they pu

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

Following aspects would a

t an item on the agenda.

3. If an item isn’t on the open agenda, reschedule

dd to the challenges in developing combination products:

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

it for discussion at a later time.

4. Give each item on the agenda a time

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

limit. If action or discussion cannot be completed during the allotted time,

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

it must be delayed until the end of the meeting.

5. After all agenda items

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

have been discussed, address the delayed items and estimate how long it will

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

Professional from academic institutions, pharmaceutical industries, health care indust

take to discuss them. Decide if the item can be discussed today or needs fu

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

rther action before a decision can be made.

6. Any delayed item should be t

.

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 first item on the next open agenda.

7. Summarize and record action items

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

Companies that provide selfless information through particip

before adjourning the meeting. Identify who is responsible for which action

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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Main Subject - How To Conduct Effective Meetings

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