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Digg It - Leadership & Teamwork
Strong, positive teamwork is defined by a leader who has a vision and the ability to inspire his or her team to work toward the realization of that vision.
The leader is not threatened in the least by the expertise and diversity of his or her team. Rather, a go
The leader is not threatened in the least by the expertise and diversity of his or her team. Rather, a go
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
od team leader engages his or her teammates in a discussion about what quality looks like, what is needed to perform and complete the job, and empowers the team members to always strive for quality improvement.
Let’s break all that down into its component parts
Let’s break all that down into its component parts
; 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
. The first is a clearly defined leader. I believe every team must have a leader. There must be someone who is in charge and makes the ultimate decisions.
Team members may take turns being the leader as long as everyone is clear who the leader is on any given d
Team members may take turns being the leader as long as everyone is clear who the leader is on any given d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
y. Another variation of that theme is to have certain people be the leader for projects that are in their area of expertise. However, in every event, there can be no question among teammates who is the leader for that day or project.
The leader needs to have a
The leader needs to have 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
vision. This is similar to Covey’s second habit, “Begin with the end in mind.” A true leader creates the end product twice---once mentality and then in its actual form. It is impossible to lead toward a fuzzy vision. People are simply not inspired to follow unce
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tainty.
Having the vision is not enough to inspire teammates to strive toward the same goal. A good team leader knows how to help each teammate see how the end product or service will be useful and what, exactly, their individual contribution is toward that end
Having the vision is not enough to inspire teammates to strive toward the same goal. A good team leader knows how to help each teammate see how the end product or service will be useful and what, exactly, their individual contribution is toward that end
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
.
How does the janitor contribute to fans’ enjoyment at a professional baseball game? By providing a clean, neat bathroom experience---that’s how. If the janitor sees himself as a critical cog in the big picture goal and he receives positive recognition for it,
How does the janitor contribute to fans’ enjoyment at a professional baseball game? By providing a clean, neat bathroom experience---that’s how. If the janitor sees himself as a critical cog in the big picture goal and he receives positive recognition for it,
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
then he is more likely to perform his job with enthusiasm.
Another component of being able to inspire one’s teammates is having a clearly defined mission that everyone, preferably, has had a part in developing, but if not, then at least team members can agree
Another component of being able to inspire one’s teammates is having a clearly defined mission that everyone, preferably, has had a part in developing, but if not, then at least team members can agree
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o the previously established team mission.
This becomes important in times of conflict between team members. When there is a dispute to be solved, it is helpful to have an already established way to measure the solution. Solutions are always held up against the
This becomes important in times of conflict between team members. When there is a dispute to be solved, it is helpful to have an already established way to measure the solution. Solutions are always held up against the
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
mission and whether or not it will move the team closer or further from the ultimate goal.
The other advantage of having a mission that has been agreed upon by all team members is that it can enhance cooperation. One of the most difficult things to manage on a
The other advantage of having a mission that has been agreed upon by all team members is that it can enhance cooperation. One of the most difficult things to manage on a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
team is an individual ego. There can be petty jealousies and a competitive spirit that can kill the cooperation of the best team. The mission statement is a way to minimize this potential for disaster.
The mission remains the focus that everything else is compa
The mission remains the focus that everything else is compa
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
red to. An individual’s action is either helpful or hurtful to the mission and dealt with accordingly. The group’s goal must always be placed above any individual’s desires or ego. Jealousy and backstabbing have no useful place on a team.
A good leader is in no
A good leader is in no
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
way threatened by the expertise and diversity of his or her team. The best leaders are always seeking information from the front line people who are doing the actual work. Without information from team members, the leader’s hands are tied behind his or her back
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
It is also critical to use team members in their areas of expertise. Leaders can’t know everything about everything. There will be team members who have skills and abilities that surpass those of the leader in certain areas. A good leader will ask for help whe
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
n it is prudent.
This is also a time to value diversity. Having a team made up of people who all do the same jobs in pretty much the same way really has no value. One person could more easily do the job than assembling a homogenous team.
The value of a team co
This is also a time to value diversity. Having a team made up of people who all do the same jobs in pretty much the same way really has no value. One person could more easily do the job than assembling a homogenous team.
The value of a team co
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
mes from its heterogeneity. Getting feedback and suggestions from people who do things differently is what will spark the creativity and the genius of the team. This is what masterminding is all about. Tap into the wealth that is already there.
Finally, a good
Finally, a good
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
eader holds the bar high. He or she does not ask his team to be average or mediocre. Average and mediocre can be easily replaced. The leader asks his or her team to collectively do their very best and when they are done, the leader asks them to always strive for
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
continuous improvement. The work is never done. The team should always be evaluating what has been implemented and be comfortable making suggestions for ways to do it even better.
Previously, I mentioned that a good leader empowers his or her teammates. Creati
Previously, I mentioned that a good leader empowers his or her teammates. Creati
.
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
g a need-satisfying environment does this. Team members must get along and know that the leader and the company have their best interests at heart. They must feel important, listened to and respected. They must have the freedom to make choices within the context
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
of their assignments and they must have some fun in their work.
It is also critical for team members to feel safe. This means that they are not fearful in any way. The team leader is critical in fostering this environment for the empowerment of the entire team
It is also critical for team members to feel safe. This means that they are not fearful in any way. The team leader is critical in fostering this environment for the empowerment of the entire team
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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