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Main Subject - Designing Your Healthy Administration - A Management Overview
Management or Leadership?
Simply stated, management ensures that things get done, in accordance with accepted policies, based on the reality of a situation. It involves deciding the how, and the when and often the who. The who can be a cross-over factor in the initial stages. It is doing it right, creating process and systems and insuring efficiency. A manager manages both the process and records the efficiency of the individual’s performance within the process.
Leadership revolves around concepts, ideas and effectiveness, enunciating what is the right avenue, establishing direction, insuring individual and team success, and necessarily imp
Simply stated, management ensures that things get done, in accordance with accepted policies, based on the reality of a situation. It involves deciding the how, and the when and often the who. The who can be a cross-over factor in the initial stages. It is doing it right, creating process and systems and insuring efficiency. A manager manages both the process and records the efficiency of the individual’s performance within the process.
Leadership revolves around concepts, ideas and effectiveness, enunciating what is the right avenue, establishing direction, insuring individual and team success, and necessarily imp
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
lies a following. It is discerning and articulating the what, the determination of what is the right thing and often who is the right person or team. Teaching, an integral part of the process, enables a targeted team to do the right things and do them right.
For an administrative plan to be effective, we must first determine what is the right thing to do. Next we approach the who, how, and when to do it; and finally we must make certain each individual and team is enabled to do, to accomplish it. In other words, we manage the process and we lead the people, educating them as necessary.
Management functions have been classically stated as Pl
For an administrative plan to be effective, we must first determine what is the right thing to do. Next we approach the who, how, and when to do it; and finally we must make certain each individual and team is enabled to do, to accomplish it. In other words, we manage the process and we lead the people, educating them as necessary.
Management functions have been classically stated as Pl
; 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
anning, Organizing, Leading and Controlling (POLC). Much controversy has arisen surrounding these principles and they have been revised largely depending on the focus of the organization. I would like to offer a perspective based on 6 elements, making room for management and leadership coexistence, each undeniably valuable in the success of any administrative plan. They are establishing objectives, organizing & planning (combined as one element of the process), motivation, communication, employee development, and finally, measurement and analysis.
Each must be addressed in any administrative venture, whether building or rebuilding, or merely
Each must be addressed in any administrative venture, whether building or rebuilding, or merely
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tweaking your administration, from the smallest detail to the most comprehensive reorganization. And since there is nothing new on the planet, merely a reshaping of what already exists, each will be familiar to you. Management issues and direction can be effectively delineated based on these six basic functions inherent in the management/leadership process. Each is pertinent to guiding the design, or redesign and implementation of administrative proce-dures.
Establishing Objectives
The process of establishing objectives involves determining a statement of vision, and then setting the goals necessary to achieve that vision. Goals must apply
Establishing Objectives
The process of establishing objectives involves determining a statement of vision, and then setting the goals necessary to achieve that vision. Goals must apply
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to the team (the organization), the individuals within the team, as well as to those in lead-ership positions. These objectives must be a direct result of the team’s determined purpose, which should ultimately be service, either to an internal or an external client. Each objective must have as its established goal the smoother, more efficient operation of the team (department and/or organization). Each objective must also be in accordance with the acknowledged purpose(s) of the department and the larger organization. This requires interaction not only with the team members, to determine that the they are on track, but with the internal clients
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
, to insure that the goals and objectives are pertinent to their needs, as well as to the organization’s greater purposes. Translating objectives into action requires utilizing all available resources, as well as networking and interfacing with others on the management team organization wide, who have displayed effectiveness in their positions.
Organizing/Planning
Efficiency in this area is critical, in order to implement, clearly and realistically, the goals and objectives enunciated by upper level leadership. This involves the ability and resources to develop well-detailed plans and realistic schedules, while maintaining a critical balance
Organizing/Planning
Efficiency in this area is critical, in order to implement, clearly and realistically, the goals and objectives enunciated by upper level leadership. This involves the ability and resources to develop well-detailed plans and realistic schedules, while maintaining a critical balance
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
between the vision (broad view) and operation (day-to-day activities).
All the while there must be continuing communication with all levels involved, at all stages of the process. The existing
structure of a department in the case of a redesign is all-important, along with an ability to delegate responsibility, while continuing to monitor and control the outcome.
Structure, though it may be transitional, must be moved to the forefront of the plan, often a challenge in an atmosphere in which performance is occurring hand in hand with design and implementation. It must, however, assume a position of precedence.
Motivation
Motivating is
Motivation
Motivating is
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
a critical function of any process, one that addresses the issue of control. Motivation provides a purpose, the impetus, for an action, or for changing it. It is complex at best and takes more than one form, depending on the level of the individual or team, the level of the manager, and the product or service provided by the department or organization. It is acknowledged by experts, that the feelings of the individual or team toward the motivator are key to the degree of motivation achieved. It becomes ideal then to have the full cooperation of those directly affected by the process or process change.
There are those who maintain that humans
There are those who maintain that humans
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cannot be motivated but are solely self-motivated. Adoption of this viewpoint presents somewhat greater challenges, and it becomes highly beneficial for the leader to have a good understanding of the individuals he is working with. He must know what makes each tick.
The use of unilateral power is an effective form of motivation in situations in which individuals need to be overtly stimulated or influenced to comply with direction, rules, and policies. This is most effective with entry level employees, or those whose responsibilities are basic, repetitive, and easily measurable. It is not an effective long-term motivator for those whose role
The use of unilateral power is an effective form of motivation in situations in which individuals need to be overtly stimulated or influenced to comply with direction, rules, and policies. This is most effective with entry level employees, or those whose responsibilities are basic, repetitive, and easily measurable. It is not an effective long-term motivator for those whose role
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
is largely self-directed. These individuals require a motivation that stimulates their ability to perform independently, fostering a higher performance level, and building a spirit of collaboration within the team.
It is often effective and highly productive to involve key staff members in the design and implementation of administrative procedures, particularly those involving drastic change to the existing structure. It is of utmost importance to keep in mind that humans do not react well to change, regardless of proven benefit to their condition. Change implies upheaval, disturbance of the status quo, and humans will resist it. Involving
It is often effective and highly productive to involve key staff members in the design and implementation of administrative procedures, particularly those involving drastic change to the existing structure. It is of utmost importance to keep in mind that humans do not react well to change, regardless of proven benefit to their condition. Change implies upheaval, disturbance of the status quo, and humans will resist it. Involving
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
them in the process, on whatever level seems reasonable, is definitely wise to con-sider.
Communication
Nothing short of great communication is essential. This cannot be over sated. Communication is the dissemination or exchange of information on the true state of the situation, all information being as accurate and understandable as possible. Great communication is timely, pertinent, and requires confirmation that the message has been understood; it is unilateral. The more ways in which information is given, the more believable it is, the more likely it is to initiate action. By means of clear communication from the organization environme
Communication
Nothing short of great communication is essential. This cannot be over sated. Communication is the dissemination or exchange of information on the true state of the situation, all information being as accurate and understandable as possible. Great communication is timely, pertinent, and requires confirmation that the message has been understood; it is unilateral. The more ways in which information is given, the more believable it is, the more likely it is to initiate action. By means of clear communication from the organization environme
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
nt, a course of action is determined, and information is provided concerning its relationship to those involved. A manager/leader must be a great communicator, or very simply, goals will not be met. This may not be obvious at once, but will manifest in future, multi-level failures for the organization. It is by this rela-tively simple stumbling block that many truly great plans are crushed.
Employee Development
Developing people is crucial to any organization, and developing existing staff members during a period of growth or alteration of the administrative process is not only practical, but often profitable. Leadership cannot develop peop
Employee Development
Developing people is crucial to any organization, and developing existing staff members during a period of growth or alteration of the administrative process is not only practical, but often profitable. Leadership cannot develop peop
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
le, but can attempt to provide an environment rich in opportunity and resource, in which individuals are encouraged to develop themselves. It is critical to realize when mistakes are a natural part of the learning process, and when they are a valid reason for strong recommendations regarding continuation or termination of an assignment. In the former instance, mistakes viewed positively will generally be enthusiastically corrected.
A critical element in the area of development is appropriate placement. This is an area in which you must simply bite the bullet and assume placement responsibility. You must gain a sound appreciation for the trus
A critical element in the area of development is appropriate placement. This is an area in which you must simply bite the bullet and assume placement responsibility. You must gain a sound appreciation for the trus
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
t placed in you by the successful candidate. This is not the place for a cavalier attitude. If you are experienced at hiring, you also understand that finding a fit for your company and its culture is not the same as fitting the individual to the position. This can be one of the costliest flaws in company procedure, affecting cost and performance on every level. Hiring the right people is only the beginning of the process, and simply assures that your new hire will probably acculturate successfully, submitting readily to the vision and mission of the organization. Place them properly within the organization, and you will have a long-term con
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
tributor, one whom can count on during transition and periods of growth.
Another important element of management’s role in employee development is to clarify that the goal is excellence in all pursuits, and to further define excellence as it applies to a specific endeavor. In the majority of instances, employees in such an atmosphere will strive to attain excellence, with little or no external prompting. The assumption is that everyone enjoys success, and most people welcome an achievable challenge. It is necessary to have a clear vision of the point at which development issues end, and poor performance begins, and to clearly communicate this
Another important element of management’s role in employee development is to clarify that the goal is excellence in all pursuits, and to further define excellence as it applies to a specific endeavor. In the majority of instances, employees in such an atmosphere will strive to attain excellence, with little or no external prompting. The assumption is that everyone enjoys success, and most people welcome an achievable challenge. It is necessary to have a clear vision of the point at which development issues end, and poor performance begins, and to clearly communicate this
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
. It is important to note, that growing and improving is a process best achieved under relatively stable circumstances, though not impossible during the challenging period of organizational growth and transition. This is oftentimes an excellent proving ground, a period during which the stars will begin to shine.
Measurement & Analysis
Finally, management needs to measure and analyze output, both of processes and of individuals, and a function of doing it right. Employees must be made aware of their progress, either in a new setting, or a changing setting, and in the familiar one as well, in order to effectively set and adjust personal goals
Measurement & Analysis
Finally, management needs to measure and analyze output, both of processes and of individuals, and a function of doing it right. Employees must be made aware of their progress, either in a new setting, or a changing setting, and in the familiar one as well, in order to effectively set and adjust personal goals
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
and improve performance.
Great leaders take pleasure in improvement, as it is a true confirmation of the validity of the vision. Such measurement and evaluation should be designed to motivate and initiate self-governing on the part of the individual. Measurement and analysis, when employed to motivate, can be extremely effective.
When used to control or dominate, however, it can backfire. In considering the evaluation process, be certain to clearly determine in the initial stages, exactly what is being measured, a very simple step too often overlooked.
IN SUMMARY, each of these functions must be approached with sound judgment, either result
Great leaders take pleasure in improvement, as it is a true confirmation of the validity of the vision. Such measurement and evaluation should be designed to motivate and initiate self-governing on the part of the individual. Measurement and analysis, when employed to motivate, can be extremely effective.
When used to control or dominate, however, it can backfire. In considering the evaluation process, be certain to clearly determine in the initial stages, exactly what is being measured, a very simple step too often overlooked.
IN SUMMARY, each of these functions must be approached with sound judgment, either result
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ing from experience with poor judgment, or better still from solid wisdom, which circumvents the negative aspects. Each of these functions must also be approached proactively using every tool and all the available resources.
Finally, the above challenges must be met with maturity in two key areas, interpersonal skills and leadership skills. This implies sophistication, a ripeness of attitude, in relating to any given situation, that each member of the leadership team has gained as a result of experience and a willingness to continue their own personal growth process.
Interpersonal Skills
Interpersonal skills are of paramount importance. Lea
Finally, the above challenges must be met with maturity in two key areas, interpersonal skills and leadership skills. This implies sophistication, a ripeness of attitude, in relating to any given situation, that each member of the leadership team has gained as a result of experience and a willingness to continue their own personal growth process.
Interpersonal Skills
Interpersonal skills are of paramount importance. Lea
.
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
dership must treat individuals fairly, developing solid working relationships with them across all levels. This may appear to be blatantly obvious, but sadly is all too often overlooked in the name of accelerated organizational progress. Managers and supervisors must be willing to facilitate conflict resolution, as well as to confront issues surrounding relations between teams or departments, particularly during the period of growth or change in the administrative process.
Leadership Skills
A great leader has a sincere concern for the success of people he leads, treating staff members as individuals, giving credit, taking pleasure in making p
Leadership Skills
A great leader has a sincere concern for the success of people he leads, treating staff members as individuals, giving credit, taking pleasure in making p
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
eople look good. A great leader keeps the objective as simple as possible, in order to promote understanding, always acts as a role model, and stands out of the way, letting others get on with their jobs, not interfacing unnecessarily.
A true leader will make the difference between an effective administrative transition and the failure of an otherwise brilliant plan. Do not overlook the advantage of adjusting the needs of the plan to allow for the needs of the people. It is not necessary to prioritize purpose over people, or vice versa. If leadership has done its homework, everyone in the organization will arrive at the vision simultaneously
A true leader will make the difference between an effective administrative transition and the failure of an otherwise brilliant plan. Do not overlook the advantage of adjusting the needs of the plan to allow for the needs of the people. It is not necessary to prioritize purpose over people, or vice versa. If leadership has done its homework, everyone in the organization will arrive at the vision simultaneously
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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