Main Subject - Business

Whether you call it a Project Plan or a Project Timeline, it is absolutely imperative that you develop and maintain a document that clearly outlines the project

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

milestones and major activities required to implement your project.

This document needs to include the date each milestone or major activity is to be completed,

; 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 the owner of each. Your project plan also needs to be created at the beginning of the project, and a baseline version approved by the team as soon as possib

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

e.

Although you will probably not know all of the major activities required to implement your project in the beginning, it is important that you create a draft

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

of the activities you think may need to be tracked via a formal document.

Take some time and really think through what you know about the objective of your proj

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

Combination pro

ect. Look at some historical data from similar projects. You can even have a few informal meetings with knowledgeable individuals you can use as a sounding board

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

to make sure you aren't completely off base. You'll be surprised how good a draft you can develop if you put in a little effort.

With this draft you will be abl

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

e to speak with subject matter experts (SMEs) and stakeholders to flesh out the project plan. If you don't make some level of effort to develop a rough draft, yo

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

u may give a bad impression which will make it harder for you to obtain the support of the persons you need to implement the project.

After you have fleshed out

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

your draft with your core team, and some other SMEs that may not be a part of your team, you should give the document a baseline status. Your timeline / project

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

plan should not undergo many edits, if any, after it achieves baseline status.

You should document the actual date your project activities are completed. If the

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

Following aspects would a

actual completion date differs from your baseline date at anytime, you'll still have documented the date it was supposed to be completed for historical purposes

dd to the challenges in developing combination products:

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

It is also a good idea to notate where things are deleted or added, and why. That way you aren't standing there looking crazy, trying to go through the

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

crevices of your memory, when someone asks you why something you deleted isn't in the document...and trust me, someone will ask.

A few key items to include in y

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

our timeline are:

- a unique ID that your team can reference when giving an update
- the name of the task
- when the task should Start
- when the

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

task should Finish
- the actual date the task was completed
- any tasks that need to happen before other tasks can begin
- the owner of the task

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

Professional from academic institutions, pharmaceutical industries, health care indust

r> - percent complete of each task

You or the Project Sponsor you represent may decide to track or maintain more than what has been outlined above in your proj

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

ect plan. This is absolutely fine. These are just the items I have found to be vital, and a good foundation to build upon.

It is completely possible to run a pr

.

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

ject without a project plan or timeline; it's just not very smart. So, do yourself and your project team a favor... document milestones and important tasks, keep

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

Companies that provide selfless information through particip

up with the status, and you'll be that much closer to a well managed project.

Remember, it doesn't matter what you call it, it just matters that you develop it

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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Right now, as you're reading this article, notice something. Do you have a headache? No? Did you notice that you didn't have a headache until I asked that question? Stop for a minute and appreciate the fact that you don't have a headache. Celebrate that your head feels good. Do you find that a little goofy? Yet it's usually only when our head hurts that we wish we'd remember what it feels like not to have a headache. Only when we feel lousy can we appreciate what it's like to feel well. That's not a lot different than the way we view our companies or organizations - or really, our lives. We don't really think much about the things that are going well until something happens to throw us off our game. At that point we need a quick fix so we can get back to taking the health of our bodies or our organizations for granted.

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The origins of an American business icon provides us with a lesson in innovation. Our story begins at an early Wal-Mart store, located in an economically depressed region. The store gained the dubious distinction for having the largest inventory shrinkage rate of all their stores. Shoplifting was rampant.

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