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Top Articles - PC Owners - The Largest Criminal Gang Ever?
The year is 1981. IBM has just released the Personal Computer; a low cost machine it hopes will create a winning brand. Several models are produced in quick succession accompanied by an ad campaign featuring
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
a Charlie Chaplin figure. The message is clear: It’s cheap and it’s cheerful.
The growth vector for the product turns out to be a software application called a spreadsheet. Its many early forms - VisiCalc,
The growth vector for the product turns out to be a software application called a spreadsheet. Its many early forms - VisiCalc,
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
Multiplan, Lotus 1-2-3, along with WordStar word-processing and of course games all help drive hardware sales.
Nobody seems to question the rapid and promiscuous spread of these programs by copying onto 5.2
Nobody seems to question the rapid and promiscuous spread of these programs by copying onto 5.2
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
” floppy disks and passing them from person to person.
That was then. This is now. Harsh fines and jail sentences are threatened to anyone involved in doing what came naturally back in the early ‘80s. It’s
That was then. This is now. Harsh fines and jail sentences are threatened to anyone involved in doing what came naturally back in the early ‘80s. It’s
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Very Bad Thing to copy software without having a license to do so. They say ‘this stuff is ours, we want to be paid for it’, and of course they’re right.
But here is a problem. Software’s binary informatio
But here is a problem. Software’s binary informatio
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
is a kind of digital DNA, always wanting to replicate. It’s what has made and sustained the digital revolution. When transmitting information, whether from one disk to another or over the Internet, errors c
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
an be corrected, faint signals regenerated as new, and even lost portions of messages recreated. This is the essence of the digital world, and replication is its big trick.
One of the things most of us did
One of the things most of us did
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
ith our first computer was to copy something. In our early PC vocabulary COPY was the most popular word. Doing it was so easy and so immediately rewarding. It did nobody any harm – did it? The user got the s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ftware and the manufacturer got their product widely distributed.
But a company has to make money, not just gain market share, and at some point in time a shift occurred. It’s as if the manufacturers decide
But a company has to make money, not just gain market share, and at some point in time a shift occurred. It’s as if the manufacturers decide
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
to play the soccer off-side rule and grab the high moral ground at the same time - nearly every PC owner in the world was suddenly wrong-footed. And no one after all can disagree with their position. But ho
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
will they play catch-up on their lost revenues? How can they now make all their customers compliant?
A London analyst who specialises in intellectual rights issues says "the paradigm we have at present whe
A London analyst who specialises in intellectual rights issues says "the paradigm we have at present whe
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
re the license chases the product doesn't seem to be an effective mechanism for compliance by itself."
In other words trying to push a license into everywhere the software has gone without the ease with whi
In other words trying to push a license into everywhere the software has gone without the ease with whi
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
h the software got there in the first place will prove difficult. But that’s not all.
An account manager for a hardware firm in the US says "It can be difficult to keep the licensing nailed down. The hardwa
An account manager for a hardware firm in the US says "It can be difficult to keep the licensing nailed down. The hardwa
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e changes, the software moves on, departments, even companies, merge. The picture is always changing"
Demand has always fuelled innovation in Information Technology. Fluid, dynamic, competitive, the element
Demand has always fuelled innovation in Information Technology. Fluid, dynamic, competitive, the element
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
of IT constantly move. Suppliers apply different strategies at different times for different reasons: Market share, volume shipments, profit. Licensing is a big weapon in their arsenal. Then new technologie
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
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
emerge, legislation changes, big players go bust and others are created. It’s hard to see how a static and legalistic document can cover all this.
There are also the licensing arrangements that software ma
There are also the licensing arrangements that software ma
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
nufacturers employ. Licenses may be priced according to whether they are academic, charity, large volume, product upgrade, competitive upgrade, client server, thin-client, or one of several other types. On t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
p of that there are the popular service add-ons of maintenance and technical support.
Of course if we all started afresh that would make things easier. But as that’s impossible we must do two things; look a
Of course if we all started afresh that would make things easier. But as that’s impossible we must do two things; look a
.
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
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
new software in terms of correct quantity and correct type of license. That’s the easy part. The not so easy part is to look at what your company already has and see what licenses, if any, are missing or in
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
orrect.
‘The biggest criminal gang in history’ is about to be disbanded.
©2003 Jamie Plenderleith
Microsoft Certified Licensing Specialist
Chief Developer - Whaddayagot Pro Asset Management Suit
‘The biggest criminal gang in history’ is about to be disbanded.
©2003 Jamie Plenderleith
Microsoft Certified Licensing Specialist
Chief Developer - Whaddayagot Pro Asset Management Suit
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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