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Advice You - Overcome Overwhelm: 10 Ways to Slow Down and Win
It's easy to break agreements. It is especially easy to blow off agreements when you feel o
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
verwhelmed and overworked.
After all:
You have way more work to do than time to do it in.
After all:
You have way more work to do than time to do it in.
; 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
You keep putting off important tasks in order to put out fires.
You don't have the inform
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tion you need to complete the task at hand.
You have a large stack of business cards you c
You have a large stack of business cards you c
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
llected while networking.
You have no idea how to prioritize the multiple tasks you face e
You have no idea how to prioritize the multiple tasks you face e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
very day.
One form of self-discipline to solve this common dilemma is to commit to ONLY MA
One form of self-discipline to solve this common dilemma is to commit to ONLY MA
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
E AGREEMENTS THAT YOU ARE WILLING AND INTEND TO KEEP!
Just doing this can keep you out of
Just doing this can keep you out of
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
ots of trouble.
1. It means you must stop automatically agreeing to do things.
2. Instead
1. It means you must stop automatically agreeing to do things.
2. Instead
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
you must take time to think through any agreement you make.
3. Don't say "yes," say "MAYB
3. Don't say "yes," say "MAYB
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
E." Then say, "I will let you know in (15 minutes, 24 hours, or ??) after I check (the ava
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lability, my schedule, etc.) This time agreement is one you must keep.
4. Think about your
4. Think about your
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
priorities and resources, including time, energy and money before you decide whether to mak
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
the agreement.
5. Make your decision. It should be yes, no or an alternate proposition th
5. Make your decision. It should be yes, no or an alternate proposition th
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
at takes what you need into account.
6. Communicate your decision within the agreed time p
6. Communicate your decision within the agreed time p
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
riod.
7. Now, make an agreement you are definitely willing to keep.
8. Keep whatever agre
7. Now, make an agreement you are definitely willing to keep.
8. Keep whatever agre
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
ment you make.
9. If you encounter something that makes it impossible to keep your agreeme
9. If you encounter something that makes it impossible to keep your agreeme
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
t, don't wait. Communicate about the need to change your agreement at the earliest possible
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
opportunity.
10. Renegotiate a new agreement, repeating your original decision making pro
10. Renegotiate a new agreement, repeating your original decision making pro
.
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
ess.
When you think through your agreements BEFORE you make them, it becomes much easier t
When you think through your agreements BEFORE you make them, it becomes much easier t
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
stay on target, follow through and achieve success.
Copyright 2004-2006 Laurie Weiss Ph.D
Copyright 2004-2006 Laurie Weiss Ph.D
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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