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E-Folder - The Art of Remarkable Leadership
Leadership is defined as the capacity or ability to guide others to accomplish an objective. To provide leadership, one needs to be a leader.
The following is a quote that captures the essence of a great leader:
The six most important words: "I admit I made a mistake.
The following is a quote that captures the essence of a great leader:
The six most important words: "I admit I made a mistake.
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
"
The five most important words: "You did a good job."
The four most important words: "What is your opinion?"
The three most important words: "If you please."
The two most important words: "Thank you."
The one most important word: "We."
--Autho
The five most important words: "You did a good job."
The four most important words: "What is your opinion?"
The three most important words: "If you please."
The two most important words: "Thank you."
The one most important word: "We."
--Autho
; 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
Unknown
Wouldn’t you love to work with a leader who is willing to speak these words? It has been found that the most reliable predictor of employee satisfaction is trust and confidence in a company’s top leadership.
What qualities do you believe are required by a good l
Wouldn’t you love to work with a leader who is willing to speak these words? It has been found that the most reliable predictor of employee satisfaction is trust and confidence in a company’s top leadership.
What qualities do you believe are required by a good l
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ader and how does one become a leader? Although some people have natural leadership skills, good leaders are made not born. We are all involved in leadership capacities in our everyday lives. Whether we are leading a business, government, family, organization or arranging a
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
dinner or household, leadership abilities are required.
Five of the most important skills of an effective leader are being trustworthy and ethical, the ability to be an effective communicator, good self-management, maintaining focus, and courage. Let’s explore these qualit
Five of the most important skills of an effective leader are being trustworthy and ethical, the ability to be an effective communicator, good self-management, maintaining focus, and courage. Let’s explore these qualit
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ies.
First, a leader’s credibility is based on what he or she does and their beliefs and values (which incorporates an attitude of service regarding the needs of others.) If there is a discrepancy between actions and values than the leader is out of integrity. This clearly
First, a leader’s credibility is based on what he or she does and their beliefs and values (which incorporates an attitude of service regarding the needs of others.) If there is a discrepancy between actions and values than the leader is out of integrity. This clearly
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
will be noticed and the leader will be less effective.
Second is being a good communicator. When a leader is clear about their direction and purpose then it is easy to convey this to others. If a leader is having trouble articulating what he or she wants to have happen, th
Second is being a good communicator. When a leader is clear about their direction and purpose then it is easy to convey this to others. If a leader is having trouble articulating what he or she wants to have happen, th
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 it would be valuable to re-evaluate the goals. As well when one doesn’t have a clear picture about what is going on then it would be a challenge to talk about it.
The third quality is self-management or what many describe as life balance. It is important to acknowledge
The third quality is self-management or what many describe as life balance. It is important to acknowledge
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he emotional, spiritual, physical and psychological aspects of life. People are not one-dimensional. If one is physically exhausted or emotionally drained, they are not operating on all cylinders. Leaders need to continue to self-nurture in order to maintain the ability to
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
provide positive, effective leadership.
Fourth is focus. Leaders are able to see the big picture and pinpoint what is important. If they become bogged down in details, preoccupied with perfection or insist on doing everything themselves, then their focus is off. The task i
Fourth is focus. Leaders are able to see the big picture and pinpoint what is important. If they become bogged down in details, preoccupied with perfection or insist on doing everything themselves, then their focus is off. The task i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
about leading rather than doing.
The fifth skill is courage. The willingness to do something different; to be open to new possibilities and be daring enough to implement them. Let’s be clear, this does not mean that there is no fear, but rather the desire to move forwar
The fifth skill is courage. The willingness to do something different; to be open to new possibilities and be daring enough to implement them. Let’s be clear, this does not mean that there is no fear, but rather the desire to move forwar
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
in spite of it. Many companies would not exist today if owners had given into their fears.
Successful organizations have leaders who set high standards and communicate well. If your company is large it’s impossible to know all your employees, however you need to know ma
Successful organizations have leaders who set high standards and communicate well. If your company is large it’s impossible to know all your employees, however you need to know ma
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
y of them, as well as knowing what is happening. When changes are occurring, communicate the information to staff. When things go wrong, as they do from time to time, explore what occurred, rectify the errors without blaming others and move on. This sets the example for
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
staff.
One woman executive had many of the leadership skills which have been described. Her staff felt she was supportive, encouraging and helpful, a mentor and a role model. However she also had been raised with the belief that men were more successful leaders than wome
One woman executive had many of the leadership skills which have been described. Her staff felt she was supportive, encouraging and helpful, a mentor and a role model. However she also had been raised with the belief that men were more successful leaders than wome
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
. This notion interfered in her attaining higher positions within her company. To become the dynamic leader she wanted, her learning required her to explore this inhibiting belief.
In speaking with university students who had several work placements, they stated that alt
In speaking with university students who had several work placements, they stated that alt
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
ough they had learned a great deal from having good bosses and a positive work environment, they learned just as much, if not more, from jobs where the boss was difficult and an ineffective manager. From adversity can come the greatest learning. They had learned what kind
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
of environments and management they did not want to experience. Consider the bosses, managers and leaders with whom you have worked. What were the things that you liked about their style and what did not serve you well?
In order to be most effective leadership must be c
In order to be most effective leadership must be c
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
onscious. The awareness of what you are doing and how it affects the company’s objectives and the staff morale is paramount. A good leader should not only focus on what he/she thinks is best, but must also consider the greater good. It is now becoming important to think
.
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
eyond the company and consider what impact the business is having on the community and environment. Many companies are now encouraging and providing the opportunity for their employees to volunteer in the community. This directive comes from the top down, the leaders.
Gr
Gr
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
at leaders are involved in an on going process of self-study, education and action. Determine where you are on your path to providing great leadership and what actions you need to implement in order to increase your skills.
Copyright 2007, Gail Solish. All rights reserved
Copyright 2007, Gail Solish. All rights reserved
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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