Main Subject - Business

1) Where is the agenda? A meeting without an agenda is like a journey witho

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

ut a map; it will always waste your time. Once you have the agenda, make

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

Examples of combination products may in

sure that it consists of more than a list of words because this is almost

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

useless. The agenda for an effective meeting will provide a complete desc

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

ription of how the meeting will proceed.

2) What is the goal? Is the cha

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

Combination pro

r seeking an agreement, a solution, or a plan? Knowing the goal gives you

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

head start on participating effectively. Be cautious of meetings that ar

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

held just "to talk about something," because this type of meeting seldom

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

accomplishes anything.

3) What is my role? Make sure that your participat

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

on adds value to the meeting. Avoid meetings where you have a superficial

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

role, such as to find out what’s happening. In that case, ask for the mi

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

Following aspects would a

nutes. If you’re needed to work on only part of the agenda, ask if you ca

dd to the challenges in developing combination products:

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

attend only that part of the meeting.

4) How should I prepare? Make sure

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

that you know about any research, readings, or surveys required to partic

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

pate. Ask about the expectations for the other participants because this

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

could influence your preparation. Attend only if you can prepare adequate

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

Professional from academic institutions, pharmaceutical industries, health care indust

y or suggest another time for the meeting.

5) What should I bring? Should

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

you bring a laptop? Will you be asked to give a presentation? Should you

.

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

ring reports, data, or other information? Make sure that you have enough

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

Companies that provide selfless information through particip

time to obtain the tools and materials needed for effective participation

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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