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Top Adding - Creating Your Work Space
When you look around your office or your work space what do you see? I believe there are certain “tools” that are
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 must for any work space:
1. A clock or a watch. I believe it’s very important to know how long you are invest
1. A clock or a watch. I believe it’s very important to know how long you are invest
; 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
ing in each task. If you’re writing an article, how long have you been writing that article? If you are placing
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ds, how long have you been sitting at your computer placing those ads? Perhaps you are speaking with folks on Ins
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tant Messenger. It’s amazing how much time can fly by when you are chatting with others. Having a clock or a watc
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lets you be accountable for your time.
2. Your calendar. I still keep my calendar offline. Many folks keep thei
2. Your calendar. I still keep my calendar offline. Many folks keep thei
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
r calendars online. Either way, a calendar is a must. With your clock or watch, your calendar will help keep you
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
n schedule. I write in both personal and business commitments. I don’t want to tell someone I’ll call them at 2 p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
.m. tomorrow if I have to be at my daughter’s school at 2:15 p.m. tomorrow.
3. Paper and pen. I believe you shou
3. Paper and pen. I believe you shou
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
d have paper and pen everywhere. You should have paper and pen by your desk, by your bed, in your vehicle and for
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
women that carry a purse, you should have paper and pen in your purse. Ideas come to us at all times, day and ni
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
ght. When we get ideas, we need to be able to jot down our thoughts, so that we can act on them later.
4. Your g
4. Your g
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
al sheet. In order to know what needs to be accomplished today, you’ll need your goal sheet. Goal sheets can be d
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
etailed or they can be a simple task list. I believe goal sheets are very similar to road maps. Road maps tell us
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
how to get where we need to go. If we’re on familiar roads, our map can be very simple. If we are on unfamiliar r
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
oads, we need a more detailed map.
5. A phone. It’s near impossible to run a business without a phone. I have bo
5. A phone. It’s near impossible to run a business without a phone. I have bo
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
h a home phone and a cell phone. I also have a calling card for my home phone. At one time I had a separate line
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
for my business. Today, with calling card rates so low, I just use a calling card on my home phone. I know that c
.
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
lls made on the calling card are charged to the business.
My own work space also includes a bottle of water and
My own work space also includes a bottle of water and
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
my computer. I believe that with the above tools, you’ll be ready to make the most of each day as it comes to you
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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