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Main Subject - Organize your Office- Seven Solutions
1. Create a filing system with broad categories such as “Insurance” and then break those categories down further i
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
nto sub-categories (i.e., car, life, medical), alphabetizing them along the way. Devote one file drawer to each ca
; 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
egory (if possible) and use a different color for each category.
2. Create a file index for you and anyone else n
2. Create a file index for you and anyone else n
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
eding to access your files. A file index is basically a user-friendly guide to where each file is located. So if y
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ou are looking for an insurance claim, the entry in your file index may look like this: (I call it my Bible-do not
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lose!)
Insurance Claims- Insurance (I-10)
3. To minimize interruptions of your own time and others, schedule a
Insurance Claims- Insurance (I-10)
3. To minimize interruptions of your own time and others, schedule a
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
-minute meeting somewhere during the day with the people you most often need to speak with. This prevents the freq
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
uent knocking at your door you may experience! Let others know when you are available to meet with them, perhaps b
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tween 3-4 PM, for example. Ask your boss for 5 minutes of his/her time everyday to go over any questions you may h
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
ve, eliminating the need for constant interruptions. (Tip-this works great with spouses also! No more, “Honey, can
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
I just ask you to do this one thing?” Or calling him/her at the office to find out when to pick up the kids. Daily
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
meetings are much appreciated by all!)
4. Resist the need to answer your phone every time it rings. Use your voi
4. Resist the need to answer your phone every time it rings. Use your voi
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
e mail when you are working on something.
5. Prevent phone tag and wasted time on the phone. When returning phone
5. Prevent phone tag and wasted time on the phone. When returning phone
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
calls, gather all the information you need BEFORE you make the call. See if there is another person who can answer
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
your question, instead of having to wait around for a response.
6. Sort your incoming paper daily and decide wha
6. Sort your incoming paper daily and decide wha
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
you need to do with each piece of paper. Set up a tickler file to corral these to-dos. A tickler is a 1-31 file w
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
th dividers for each day of the month and months of the year. So, if you have a memo with a phone number of someon
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e you need to call back, put that paper in the tickler on a day you can return the call.
7. Use templates and for
7. Use templates and for
.
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
s anytime you can. So if people come into your office often to borrow something, instead of having them leave a no
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
e, keep a stack of “Borrowed Item Forms” for them to fill-in-the-blank and leave for you in a designated location
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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