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Advice You - Character
1. Character is Action, as well as Words
Leaders set the course for behavior as well as the strategic direction. As a leader, ot
Leaders set the course for behavior as well as the strategic direction. As a leader, ot
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
hers will watch your confidence, your integrity, your response and your enthusiasm. Demonstrating good character does not guarantee resp
; 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
ect, but it is a sure thing that you will lose respect without it. Every time that you give advice for behavior, take a moment afterward
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s to reflect if your own actions are consistent with your advice.
2. Leaders Can Not Rise Above Limitations of Character
Lack o
2. Leaders Can Not Rise Above Limitations of Character
Lack 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 strong character leads to destructive behavior. According to Steven Berglas, a psychologist at Harvard Medical School and author of Th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e Success Syndrome, leaders with weak character are destined for destruction through Arrogance, Aloneness, Adventure or Adultery. Have y
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
ou witnessed someone who suffered from one of these? What was your impression of the character of that individual, and were you not surp
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
rised by result?
3. Character makes a Lasting Impression
Think of a business associate that you have not seen in a long time. W
3. Character makes a Lasting Impression
Think of a business associate that you have not seen in a long time. W
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hen you find an old business card, see a familiar name in an email or press release, or hear the name in conversation; what is the first
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
thing that comes to your mind? Do you immediately remember an event, a success, or a failure? Typically the first response is an emotio
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nal reaction, for example: Do you like that person? Do you trust that person? Do you wonder how that individual is, or are you grateful
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
that the person is no longer in your life? Character makes a lingering emotional connection.
4. Talent is a Gift, Character is a Cho
4. Talent is a Gift, Character is a Cho
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
ice
The good news is that character is a choice, your choice. Character is defined by the numerous actions and expressions that you
The good news is that character is a choice, your choice. Character is defined by the numerous actions and expressions that you
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
make every day. With the power of your will you can modify your character. It is not as difficult as stopping a bad habit. It is as eas
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
y as introducing good habits. Make it a point to do something positive every day. Consider the power of your actions and your words. Thi
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
nk about improving and reinforcing your character every day for 30 days and watch the change in the environment around you. It will have
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
a lasting affect.
______________________________________________________
Words of Wisdom
"Leadership is the capacity and will
______________________________________________________
Words of Wisdom
"Leadership is the capacity and will
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to rally men and women to a common purpose and character which inspires confidence."
-Bernard Montgomery, British Field Marshal
"
-Bernard Montgomery, British Field Marshal
"
.
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
Never 'for the sake of peace and quiet' deny your own experience or convictions."
- Dag Hammarskjold. Statesman and Nobel Peace Pri
- Dag Hammarskjold. Statesman and Nobel Peace Pri
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
ze Winner
"Bend like a reed to accommodate others, but stand like a rock on principles."
- John Mehrmann, Executive Blueprints, In
"Bend like a reed to accommodate others, but stand like a rock on principles."
- John Mehrmann, Executive Blueprints, In
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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