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Project management knowledge and practices are best described in terms of their component proces

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

ses. These processes can be placed into five process groups (initiating, planning, executing, co

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

Examples of combination products may in

ntrolling and closing) and nine knowledge areas (project integration management, project scope m

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

nagement, project time management, project cost management, project quality management, project

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

human resource management, project communications management, project risk management and projec

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

Combination pro

procurement management).

A Project Management Rule: Embrace uncertainty. Expect the unexpected

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

. There is far more that we don’t know and can’t know than what we can anticipate. Be resilient

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

to what life throws at you. Anticipate that your team will learn something along the way that ca

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

and should change what you have promised and how you can deliver on your promises.

The core va

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

riables of the project management process, namely: product scope, quality grade, time-to-produce

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

and total cost-at-completion must all be mutually consistent and attainable.

Tracking progress

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

Following aspects would a

on a project management should be a regular part of you daily routine, even if you have other du

dd to the challenges in developing combination products:

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

ties that require your attention.

Formal methods of Project Management offer a framework to man

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

ge this process, providing a series of elements – templates and procedures – to manage the Proje

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

ct Management through its life cycle. Balancing limited labor, materials, and other resources is

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

a difficult task that earns a good Project Management top dollar.

The genesis of the project ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

nagement life cycle process, in its most basic form, is to be found in the very term "project ma

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

nagement" itself. A project has, by definition, a start and a finish.

Publishing Guidelines: Yo

.

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

may publish my article in your newsletter, on your website or in your print publication provide

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

Companies that provide selfless information through particip

d you include the resource box at the end. Notification would be appreciated but is not required

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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Participants in industry conferences often have their own display space for presentations and information handouts. It makes sense to use the opportunity to promote your business and your company where you have a gathering of people in your industry. Conference gifts offer a great way to send your message and your name home with fellow attendees at your conference.

There are a lot of people that want to get into mystery shopping but it seems to be so secretive. Here is the truth behind mystery shopping.

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