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Why should you care about my viewpoints?

Good question - you don't know me - but obviously - You're c

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

onfused and maybe even a bit fed up by your new assignment and it's lack of clarity...

Typical prob

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

Examples of combination products may in

em!

My specialty: Getting what I call "sorry ass - stranded in the ditch - projects up'n running F

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

ST!

And by fast, I mean just that...

Fast, or instant - in like 90 days or less... And in 6 to 7 mon

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

ths or less, depending on size and shape - So God-Damned Blod Trimmed - So tuned up - you wouldn't

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

Combination pro

even recognize it...

When my collegues couldn't make it - I usually was sent in to clean up the mes

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 do the 'dirty work' - And I did. - PERIOD.

When dealing with a project. My main goal is

ALWAY

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 RESULTS.

I may be tough, and sometimes you'll have to be too...

Because you see... Sometimes...

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

anagement claim they want this and that change... ..And sadly enough too... sometimes...

When you st

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

rt giving it to them - they start sabotaging you

And unless you're pretty aware of that when that sta

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

ts happening - and unless you take measures to do something about it - you're headed for danger...

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

Following aspects would a

Big Danger!

And in my world...

Usually the head of the project manager is the easiest to cut off...

dd to the challenges in developing combination products:

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

As he or she is some kind of the modern Ninja - like a King - a Queen - however with no land...

.Le

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

t to the mercy of the warlords - the CEO's and Corporate middle management...

However... A few simpl

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

e precautions will get you where you want to go, but FAST!

How?

Simply by (among a lot of things) -

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

backing up your work, every little bit of it..

And - YES!

Definitively also make sure you back-up t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ose seemingly small

- those insignificantly "un-important" things that you

- due to the "littleness"

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

of them...

- never even bothered care about...

Take Care and Much Success!

Arne Yri

"How to drag

.

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

our sorry ass - stranded in the Ditch Project - Up'n Running again Fast In 90 Days Or Less...

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

Companies that provide selfless information through particip

f="http://www.ProjectManagementMadeEasy.com" target="_new">http://www.ProjectManagementMadeEasy.com

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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