Subjects - Business

Most agendas for a meeting look like this.

* Budget

* Payroll

* Staf

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

f

* Sales

* Vutszxtn

Some people would tell me, "That's a perfectly

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

Examples of combination products may in

good agenda. I know what all of those things mean, except, uh, 'vutsz

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

xtn'." The point is, vutszxtn means as much to you as the other terms

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

mean to the other participants. For example, does budget mean increa

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

Combination pro

se the budget? Plan a budget? Report on the budget? Reduce the budget

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

? Complain about the budget? Make fun of the budget? Or what?

An agend

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

like the one above could launch a meeting that considers all of the

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

possibilities mentioned above. Instead, you may have wanted to realloca

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

te funds from one department to another.

A proper agenda specifies e

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

verything that the participants need to know to make the meeting effe

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

Following aspects would a

ctive. It should contain:

Goal: A clear description of the results exp

dd to the challenges in developing combination products:

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

ected by the end of the meeting, such as a decision, agreement, or so

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

lution.

Outcome: The reason (or benefit) for achieving the goal.

Acti

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

ities: A detailed list of the activities that will be used in the meeti

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

ng. This should be so complete that someone else could use it to lead

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

Professional from academic institutions, pharmaceutical industries, health care indust

your meeting.

Logistics: Everything that the participants need to kno

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

w to contribute to an effective meeting. This can include directions

.

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

to the meeting room, instructions on how to prepare, and a list of th

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

Companies that provide selfless information through particip

ings to bring.

A complete agenda will help you hold effective meetings

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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