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One of the first consulting jobs that I ever got was in project management. And let me tell you, there is no greater overwhelming responsibilty than bei

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

ng a project manager and it is something I will NEVER do again. So what exactly is project management and what does a project manager do? Well, that de

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

Examples of combination products may in

pends on what the business is. Some projects are more overwhelming than others. Since I want to keep this article strictly to my own experience I will

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

go over project management of an automated packing company.

This company packed ladies' shoes. But not through the conventional method that you might t

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

hink. The actual packing was done by real flesh and blood people but the system used was totally automated and mind boggling to say the least. I'm not g

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

Combination pro

oing to get into the specifics of how the system worked as this is an article on the actual project management itself but you do need to understand the

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

pieces involved so I will cover them as needed.

Well, the first thing as project manager that I had to do was work with the budget I was given. A proje

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

t manager is not the ultimate decision maker. That's the person above him, who is usually an executive vice president. In my case it was a divisional ma

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

nager. A budget was presented to me and I had to set up the project within the constraints of the budget. To do that I had to determine what the project

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

needed to succeed.

In this particular project this was what was needed. The hardware of the packing system itself had to be built from scratch so engi

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

neers had to be brought in to construct the system. These were contracted and paid by the hour, so a time estimate of how long it would take to complete

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

Following aspects would a

construction was made. Then there was the computer software to run the equipment after it was built, so programmers had to be hired. Also it had to be

dd to the challenges in developing combination products:

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

taken into consideration that the programmers would need to be kept on even after the project was finished in case there were bugs found or enhancements

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

that needed to be made. Then there were the workers themselves, the ones who actually packed the shoes, which also included managers to oversee the wor

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

ers, so a personnel budget had to be made and stuck to. In this case we were way over budget so personnel had to be cut which cut down production.

Then

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

there was the quality assurance team that had to be put together to make sure that the boxes were packed correctly. Then there was the security team th

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

Professional from academic institutions, pharmaceutical industries, health care indust

at had to be put together to make sure there was no theft. All of the above ultimately came down on yours truly. I'm not ashamed to say the project was

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

a failure on several levels. The machines didn't work as efficiently as expected. The programmers were not very competent and there were a lot of bug

.

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

s. Production didn't meet expectations. We couldn't pay enough to get skilled packers. It was just one thing after another. After one year the projec

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

Companies that provide selfless information through particip

t was abandoned. I was out of a job and I never did anything like this again.

Yes, project management. It's 2 little words with a ton of responsibility

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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How far are you out on the proverbial limb driving change? What kind of support do those above you provide? You'd be surprised at some of the Bozo's out there disguised as leaders. Read on and learn what 'not to do' when leading change.

To be a successful entrepreneur you are going to have to learn to deal with failure. There is no way around it. Thomas Edison tried over ten thousand different experiments before he finally demonstrated the first incandescent light bulb on October 21, 1879.

Workflow is the manner of managing office work based on the specific requirement of the individual work item. It thus involves timely and effectual response. Hence this assures analyzing, providing solutions and expediting all transactions.

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