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Managers spend much of their time in meetings. But some junior staff use meetings to showcase

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

themselves. Or they invite their boss to help with work that they should be doing. In either

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

Examples of combination products may in

case, such meetings waste your time.

Here are five questions that you (or your assistant) mu

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

t ask before agreeing to attend a meeting.

1) Where is the agenda? A meeting without an agen

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

a is like a journey without a map; it will always waste your time. Once you have the agenda,

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

Combination pro

make sure that it consists of more than a list of words because this is almost useless. The a

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

enda for an effective meeting provides a complete description of how the meeting will proceed

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

2) What is the goal? Is the chair seeking an agreement, a solution, or a plan? Knowing the

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

oal gives you head start on participating effectively. Be cautious of meetings that are held

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

just "to talk about something," because this type of meeting seldom accomplishes anything.

3

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

What is my role? Make sure that your participation adds value to the meeting. Avoid meetings

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

Following aspects would a

where you have a superficial role, such as to find out what’s happening. In that case, ask fo

dd to the challenges in developing combination products:

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

the minutes. If you’re needed to work on only part of the agenda, ask if you can attend only

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

that part of the meeting.

4) How should I prepare? Make sure that you know about any resear

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

h, readings, or surveys required to participate. Ask about the expectations for the other par

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

icipants because this could influence your preparation. Attend only if you can prepare adequa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ely or suggest another time for the meeting.

5) What should I bring? Should you bring a lapt

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

op? Will you be asked to give a presentation? Should you bring reports, data, or other inform

.

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

tion? Make sure that you have enough time to obtain the tools and materials needed for effect

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

Companies that provide selfless information through particip

ve participation.

These questions will help you look like a success when you attend 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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