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Main Subject - Taming the Paper Tiger at Home
Have you ever sat down at the kitchen table with the day’s mail and started sorting it into piles?
• bills (you always recognize those first!),
• “to read” pile (that’s always the tallest),
• stuff to go in the wastebasket (but that’s on the other side of the room),
• papers to discuss with your significant other (who isn’t there at
• “to read” pile (that’s always the tallest),
• stuff to go in the wastebasket (but that’s on the other side of the room),
• papers to discuss with your significant other (who isn’t there at
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
the moment), and finally
• “I don’t even know how I got this” pile (but you really want to read it!)
Then the phone rings -- or the kids come in -- or it’s time to go to a meeting. By this time, you can’t remember which pile is which, and you don’t have time to think about it – so you scoop it up into a bigger pile and put it in the b
• “I don’t even know how I got this” pile (but you really want to read it!)
Then the phone rings -- or the kids come in -- or it’s time to go to a meeting. By this time, you can’t remember which pile is which, and you don’t have time to think about it – so you scoop it up into a bigger pile and put it in the b
; 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
ay window. This goes on all week – in a different place each time! Saturday night you have company coming – and you certainly don’t want your friends and colleagues to think you’re disorganized, so you stuff everything in a drawer…or under the bed.
If you can identify with this scenario, you’re not alone. Research shows the average pe
If you can identify with this scenario, you’re not alone. Research shows the average pe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
son spends 150 hours per year looking for misplaced information! Certainly nothing creates a crisis in a household faster than when your 15-year-old needs a copy of his birth certificate to get into driver’s Ed class – or the IRS wants proof of that $200 deduction you took on your taxes three years ago –and you can’t find it.
Are you l
Are you l
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ooking for a way to stop this endless cycle of clutter and crisis – and be able to find what you want (and better yet, let other members of the family find what they need themselves!)? Here are some principles to help you “attack the stacks!”
Today’s mail is tomorrow’s pile. Don’t worry about the piles from yesterday – they’ll take care
Today’s mail is tomorrow’s pile. Don’t worry about the piles from yesterday – they’ll take care
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
of themselves in time. Your road to success starts by establishing a “paper management center” in your house – a place to put new papers where you will go regularly to manage your mail. Caution: Make sure it is a place you like to be! If you pay bills and make phone calls while you’re cooking or watching the kids, a corner in the kit
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
hen may be best – but if you only work in solitude, creating a cozy office in a corner somewhere may be more effective. Eliminate everything from your paper management center except what you know you will use.
Clutter is postponed decisions?. The key to your new system is to decide now! As you take papers out of your “In Basket”, rem
Clutter is postponed decisions?. The key to your new system is to decide now! As you take papers out of your “In Basket”, rem
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
ember The FAT System?. There are only three decisions you can make: File, Act, or Toss. In other words, if you want to eliminate the “fat” from your desk and your like, think “FAT”!
Instead of taking papers out of your “In Basket” and putting them back again without making a decision, ask yourself, “What’s the worst possible thing th
Instead of taking papers out of your “In Basket” and putting them back again without making a decision, ask yourself, “What’s the worst possible thing th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
at would happen if I didn’t have this piece of paper?” If you can live with your answer, toss the paper!
Practice The Art of Wastebasketry? Determine whether you want to keep each piece of paper at all by asking yourself these Art of Wastebasketry? questions: 1. Does this require any action on my part? 2. Does this exist elsewhere? 3.
Practice The Art of Wastebasketry? Determine whether you want to keep each piece of paper at all by asking yourself these Art of Wastebasketry? questions: 1. Does this require any action on my part? 2. Does this exist elsewhere? 3.
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
s this information recent enough to be useful? 4. Can I identify specific circumstances when I’d use this information? 5. Are there any tax or legal implications? If you answer “No” to all the above questions, but are still not comfortable throwing something away, ask one last question: 6. What is the worst possible thing that could happ
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
en if I did not have this information? If you can live with your answer, toss – or recycle it – and live happily ever after!
Half of any job is using the right tool. A major factor in your success at attacking your stacks will be using the right tool. Here are some essentials:
1. A wastebasket/recycle bin – or shredder, if you’re conc
Half of any job is using the right tool. A major factor in your success at attacking your stacks will be using the right tool. Here are some essentials:
1. A wastebasket/recycle bin – or shredder, if you’re conc
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
erned about confidentiality.
2. An “In Basket” to hold mail and other papers you haven’t look at yet.
3. An “Out Basket” for papers you need to take someplace else.
4. A “To File Basket” for papers you need to put in your reference filing cabinet at a later time.
5. A calendar for scheduling your time and tracking other family member
2. An “In Basket” to hold mail and other papers you haven’t look at yet.
3. An “Out Basket” for papers you need to take someplace else.
4. A “To File Basket” for papers you need to put in your reference filing cabinet at a later time.
5. A calendar for scheduling your time and tracking other family member
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
s schedules.
6. A Rolodex (or computer program such as Outlook) for managing names and contact info.
7. A small plastic file box (without a lid!) designed to hold a dozen or so hanging files for papers requiring your action.
8. A filing cabinet for reference files, which can be located outside your paper management center.
Create a
6. A Rolodex (or computer program such as Outlook) for managing names and contact info.
7. A small plastic file box (without a lid!) designed to hold a dozen or so hanging files for papers requiring your action.
8. A filing cabinet for reference files, which can be located outside your paper management center.
Create a
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
“Finding System” Does just the idea of filing give you knots in your stomach? Not surprising – most filing systems don’t work! Why? Because the same information can be filed under “Car”, “Auto” “Vehicle” or “Chrysler” – and it’s highly unlikely that any two family members would agree on what to name a file, much less be able to rememb
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
er it when they want to find it later.
The solution to this age-old problem: A File Index – a list of the names of your files. You can create a File Index as a word processing document – or you can use Taming the Paper Tiger software (www.thepapertiger.com) to generate an alphab
The solution to this age-old problem: A File Index – a list of the names of your files. You can create a File Index as a word processing document – or you can use Taming the Paper Tiger software (www.thepapertiger.com) to generate an alphab
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
tical list of your files automatically. (The system is so simple, your kids can help you file!)
From Ideas to Action But what about those papers that do require your action? Bills to pay, phone calls to make, things to discuss with another family member. Some projects may require a folder of their own, such as “PTA Fundraiser” or “Ne
From Ideas to Action But what about those papers that do require your action? Bills to pay, phone calls to make, things to discuss with another family member. Some projects may require a folder of their own, such as “PTA Fundraiser” or “Ne
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
w York Trip.”
Often we shuffle papers from one side of the desk to the other because there are so many things that need to be done. To solve this problem, create an Action File System for recurring activities. To identify what Action Files you need, ask the question, “What is the next action I need to take?” Never mind that there are
Often we shuffle papers from one side of the desk to the other because there are so many things that need to be done. To solve this problem, create an Action File System for recurring activities. To identify what Action Files you need, ask the question, “What is the next action I need to take?” Never mind that there are
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
several things you need to do! Just file the papers according to the next action. Typical answers include:
• Call
• Calls Expected
• Data Entry
• Discuss with …
• Errands
• On-Line
• Pay
• Photocopy
• Write
Put these Action Files in a desktop file holder, along with the current projects yo
• Call
• Calls Expected
• Data Entry
• Discuss with …
• Errands
• On-Line
• Pay
• Photocopy
• Write
Put these Action Files in a desktop file holder, along with the current projects 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
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
are working on, so you will have a visual reminder. This system encourages effective time management – when you are making one phone call, you can often squeeze in another one – since all the papers requiring phone calls are in one place. Afraid you’ll forget to look in the file? Make a note in your calendar on the day you need to ta
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
ke the action.
Does this system guarantee that your kitchen table with never be piled with papers? Hardly! But you will be able to clean up the clutter quickly, and know exactly where to put it. Your ability to accomplish anything is directly related to your ability to find the right information at the right time. Happy paper taming
Does this system guarantee that your kitchen table with never be piled with papers? Hardly! But you will be able to clean up the clutter quickly, and know exactly where to put it. Your ability to accomplish anything is directly related to your ability to find the right information at the right time. Happy paper taming
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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