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A project is an assignment or task taken up to achieve a specific goal. The development and introduction of new services or of a management informatio

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

n system are instances of a project. A project is different from the continuous or day-to-day processes of a company. It is confined within cost, time

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

Examples of combination products may in

, and quality constraints. As a consequence to it a special team of expertise is appointed to manage a project.

Project management as the name sugges

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

ts is all about nurturing or handling a project. This is done with the aid of requisite knowledge about the project, skills and techniques to complete

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

the project within fixed tenure and resources. Project management involves step-by-step procedure along with a prudent approach towards the project.

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

Combination pro

At first the concerned organization prepares an outline of the project. This includes knowing and writing down what the project is all about, the cos

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

t involved in the project, the amount of resources needed. A thought is also given to the tentatively earliest possible time within which the project

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

an be completed. Once the budget and other nitty-gritty’s about the project are known the organization looks for sponsors and a project manager. If th

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

e individual sponsoring the project is skilled and efficient enough, he too can be its manager.

The project manager then appoints a team of people to

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

work under him. Together with the team the manager of the project prepares a project plan. This plan is not just about the cost and time factors but

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

also regarding the manner in which the project is to be initiated and covered up later. This requires lot of discussions and settlements between the p

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

Following aspects would a

roject manager and the team of employees.

The implementation stage of a project is where the project is put to execution as decided. While executing

dd to the challenges in developing combination products:

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

a project its progress and managing changes need to be carefully monitored. At this point in order to harness the resources well the project manager m

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

ight feel the need to expand his team. For instance marketing of the product may be suffering due to more heed being paid to its manufacturing or due

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

o lack of good marketing executives. This may also involve contacting new companies and organizations. Thus a set of people needs to be readily appoin

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

ted to take charge of this. However then it is always at the onus of the manager to equip the new members with a proper and complete knowledge of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

project. In some cases training may also be imparted.

After all these stages are over, the project comes at its stage of completion. This is known as

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

the close down stage. Here the project manager safely handles the completed work in the hand of the client or the customer. Once a project is finishe

.

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

d and handed over, a project review meeting should be held to study the work done, encourage if something good was discovered during the project and a

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

Companies that provide selfless information through particip

lso learn from the mistakes made. These should also be documented and later published in warts and all. This acts as a great help in future assignment

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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