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Complex projects require sophisticated software and scheduling tools, however simpler

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

and more straightforward projects involving only a few people over a relatively short

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

Examples of combination products may in

period of time require a much simpler approach.

Usually, a simple project will have a

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

few steps which are dependent on other steps taking place first, and will be relative

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

ly straightforward to coordinate. An example might be creating and implementing a mar

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

Combination pro

eting plan for a one person business, painting a single room, baking a cake, planning

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

a weekend away for two, building a garden shed etc.

With simple projects, a tool such

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

as a Gantt chart may make over complicate the project scheduling. Unless all team me

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

mbers are trained in the tool then the use of the tool may itself lead to poor communi

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

cation and an unsatisfactory result.

A simple project such as those identified above

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

ay only require a timetable and/or an action plan. All those in the project team shou

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

Following aspects would a

ld be communicated with as to their tasks content and timing. Timetables can then be n

dd to the challenges in developing combination products:

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

egotiated and agreed, actions lists or diaries/calendars can be used for recording and

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

planning purposes.

All projects have control points and required deadlines, where pr

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

ogress is monitored and measured. In the event that a deadline is missed then the over

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

ll impact on project completion time can be assessed, and if necessary new timetables

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

Professional from academic institutions, pharmaceutical industries, health care indust

drawn up, re-negotiated and agreed.

Action Plans are lists of tasks/individual actio

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

ns that are carried out to achieve a single and objective or outcome – in this case, 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 specific project. Action Plans focus on the achievement of a single goal, the acti

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

Companies that provide selfless information through particip

on may then be translated in to a to-do list/diary cum calendar which cover many goals

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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