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In a perfect world, all Information Systems (IS) would bring the necessary structure to

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

ongoing processes, consequently improving them. Glitches in project and process manage

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

Examples of combination products may in

ent would automatically be fixed. The challenge for developers of project and process

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

management software is that business professionals now demand this “perfect world” to b

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

come a reality.

Many business professionals receive a fat slap in the face after imple

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

Combination pro

menting project process management software. It looked perfect, with its long list of

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

enefits and features -- the mistake was looking only at the diversity of functionalitie

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

s.

Information Systems are there to maximize efficiency and minimize human errors. A

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

ood tool is capable of reflecting existing processes rather than imposing processes. I

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

mposed processes are typically theoretical or defined by somebody other than the creato

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

of those processes. The best tools should also be capable of adjusting themselves to

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

Following aspects would a

pdates to processes.

This makes flexible, end-user defined applications the best solut

dd to the challenges in developing combination products:

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

ions for project and process management. Yet, not many people look at “user-control” a

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

a requirement that must be included on the list of a solution’s features and benefits.

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

User-controlled systems are flexible enough to reflect the current processes of any or

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

anization, as well as to accommodate any future changes. And these changes can be done

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

Professional from academic institutions, pharmaceutical industries, health care indust

by the end-user rather than a software development company.

Don’t be fooled by a long

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

ist of features and benefits on a flashy website promoting a project and process manage

.

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

ment solution that is not flexible. A user-customizable platform is a must for any org

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

Companies that provide selfless information through particip

nization wanting to maximize efficiency through project and process management software

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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