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Advice You - Motivation with Direction
Motivation empowers performance. Motivation with direction empowers positive performance. It can be easy to generate enthus
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
iasm amid success. How can you be inspirational in your communication during periods of duress?
How would you react to the
How would you react to the
; 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
following observations?
"We missed our quota by 50k this month, so you need to do an extra 60k next month to make up f
"We missed our quota by 50k this month, so you need to do an extra 60k next month to make up f
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r it."
"We went over budget this month, so you need to reduce your expense next month."
"We only made 75% o
"We went over budget this month, so you need to reduce your expense next month."
"We only made 75% o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
f plan this week, so you need to do 125% of plan next week to make up for it."
The good news about these statements is
The good news about these statements is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
that the shortcoming is clearly defined.
The bad news about these statements is that there is no clear direction.
The re
The bad news about these statements is that there is no clear direction.
The re
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
ult of clearly identifying failures or shortcomings without corresponding direction is often heightened frustration by all
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
involved.
Rather than merely defining the gap or challenge, be prepared to collaborate on crafting solutions.
"We miss
Rather than merely defining the gap or challenge, be prepared to collaborate on crafting solutions.
"We miss
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ed our quota by 50k this month. What can I do to help you achieve an extra 60k next month?"
"We went over budget th
"We went over budget th
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 month. Let's review the budget together and look for areas to reduce expenses next month."
"We only made 75% of p
"We only made 75% of p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lan this week. Help me understand the reasons we were below plan and what I can do to help us achieve 125% next week."
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
Identify specific gaps, express mutual commitment, make a plan, write it down and do it. Does this seem simple? Does it se
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
m obvious? It can be very easy to point out a problem to someone else and then simply walk away. Collaborating on a solutio
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
n with planned activities to improve the situation requires commitment and obligation. Make a conscientious effort to conti
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
nually invest interest in understanding shortcomings and spend mutual energy for making improvements. Your direction will i
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
spire motivation with positive direction.
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Words of Wisdom
______________________________________________________
Words of Wisdom
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
"The beatings will continue until the moral improves."
- Anonymous (unless you have heard it)
"All your power is in your
"All your power is in your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
people. Your job is enabling everybody to contribute to their fullest."
- Alan R. Mulally, Executive Vice President, Boein
.
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
"If you don't understand that you work for your mislabeled 'subordinates', then you know nothing about leadership. You kn
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
ow only tyranny."
- Dee Hock, founder and CEO, Visa International
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_____________________________________________________
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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