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    Introduction

    Every organization whether small or big, requires efficient leadership. For every organization to work smoothly and in well coordinated manner, it is essential to have a proper leadership and guidance. In industrial set-ups leaders are either selected by the employees or by the employers. However, it is ideal if both employees and employers take joint decision for picking the leader. Proper and effective selection of the leader depends u
    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
    pon the understanding of the management by evaluating the nominee for the leader. The three levels of management face the same problem of how to deal with and lead people. The three level of management are-top management (the CEO), middle management (the boss) and front line management (foremen and supervisors). Leadership is a two way process where the leader influences the followers and the followers influences the leader. The emergence of leadersh
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    p and its functions in a group are determined by the structure, situation and tasks of the group. Every successful leader has four ‘C’s common in them- Character, Communication skills, Consistency & the Creativity which required for problem solving.

    Types of leadership styles

    There are many types of groups like political parties, religious group, industrial organizations, technical organizations, etc. It is not possible to follow the same format of
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eadership style in all types of groups, therefore we come across different styles of leadership. They are as follows:-

    1) Autocratic leadership

    The leader determines all the policies, he dictates work task and work companies of each member. He is rigid disciplinarian and believes that praise will spoil the members. Here the group members tend to feel insecure, tense, aggressive and egocentric.

    2) Compassionate autocratic leadership

    The leader domi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    nates all employees and is the source of all standards. He hardly recognizes his autocracy. Here the group members tend to demonstrate a slow regression to more submission, dependency and inability to accept responsibility.

    3) Democratic leadership

    The democratic leader evokes maximum involvement and participation of every member in the group activities and in the determination of the group goals and objectives. He shares group decisions, gives reas
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ns for it and devotes time for planning. He seeks co-operation and participation of the co-members. The group members here tend to feel more confident, secure, enthusiasm is high, and the group works as a closely knitted family.

    Thus from the above description of different styles of leadership, it is apparent that democratic style of leadership is the most practical and positive form. Basic traits of successful leadership

    Leaders are those members
    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
    f the group that influence the activities of the group. If an individual in the group is perceived by the group as a means to the goal because of his personal characteristics like knowledge, skill, self-confidence, expert or anything else, then he is likely to emerge the leader. The successful leaders are assumed to possess more or less certain traits:-

    a) Self confidence is foremost important quality of any successful leader.
    b) He is liked by
    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
    his follow men.
    c) Possess technical knowledge about his field.
    d) He is respected by his fellow men.
    e) Acceptance by other group members.
    f) He is flexible in nature, adjusts rapidly to changing conditions.
    g) Has sensitivity towards feel for people.
    h) Possess intellectual ability.
    i) Has self-control, creativeness and administration qualities.
    j) Possess foresight for the future, sees new opportunities, sees
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    and acts on new opportunities.
    k) Has human relations skill to motivate the group members and get them to work together.
    l) Ability to do planning and administrate.
    m) Receives loyalty and co-operation from other group members.
    n) Has decision making ability.

    Leadership is basically behavioral, situational or else related to the interaction of the leader and the group. It is not essential for all the successful leaders to possess
    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
    every mentioned traits, but have a combination of certain essential traits to make them successful like-self confidence, motivation, decision making ability, goal-oriented, knowledge or anything else. The best method to examine leadership is by looking at bad and good leaders, and observes how they differ with each other in their traits. Good leaders are generally assumed to be member-oriented, accept suggestion from the group, rewards good work, main
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ain internal harmony and encourages participation of group in planning and goal setting.

    Different functions of leaders

    1) The leader is the top coordinator of the various activities of the group. He is responsible for the execution of the policies.
    2) A leader is expected to be the source of readily available information and skills.
    3) The leader should be the controller of in-group activities.
    4) To frame and formulate group goals
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    and policies.
    5) A leader serves as an example to the group as how they should be and how they should do.
    6) He is looked upon as a father figure to whom the groups look upon for identification for transmission for feeling of submissiveness.
    7) The leader serves as ideologist for the group. He is the source of beliefs for the group members.
    8) A leader serves as planner about the ways and means by which a group could achieve
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    goals.
    9) A leader is the representative of its group to other groups for external relation and communication.
    10) A leader has the power to give rewards or punishments to the group members for their work whatever is appropriate for smooth functioning of the group.
    11) A leader also serves as a target for group aggression of frustrated and disillusioned group members. A leader is target of positive as well negative reinforcement a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    so.
    12) To give thoughtful attention to the needs of people for satisfying relationships, to lead to a comfortable friendly atmosphere and work tempo.
    13) The leader should be readily available to all employees so establish effective subordinate- superior relationship.

    In more stable and formal corporate establishments all leadership functions may be necessary. The objectives of the group play important part in deciding primary functions
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    of the leader. The most important function of the leader is to maintain smooth channels of communication among the group member and the leader. Effective communication is however a joint process of the leader and group members. The top 5 mistakes by a leader

    1) A leader should not do favoritism and discrimination among the group members based on personal likes and dislikes.
    2) A leader should not make other members of the group feel inferior
    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
    o him by trying to make them show off that he knows more than them and is more knowledgeable.
    3) A leader should not punish any fellow group member liable to punishment in front of the other members but should be told in private.
    4) A leader should not base his actions on the fact that he is on a superior position but should be fair in his working.
    5) An effective leader issues few but concrete orders rather than superfluous orders
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nd should also remember the orders he has given to avoid confusion and conflict in the group.

    Leadership has been defined as the ability to produce meaningful change but in this 21st century change has a way of happening with or without leadership. The leader’s role becomes that of change management and control.

    The ability to get onto the correct path for creating your own effective leadership style stems from within the individual. Successful le
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    aders agree, however, that the more you do your homework the less the need for any tricks. Know your material, prepare with care in advance - then you have confidence in your developed and natural leadership traits and skills.

    The best way to study and to define leadership should be in terms of what leaders do rather than what leaders are. There are mainly two dimension of effective leadership are –concern for people and concern for production. Colla
    .

    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
    oration between superior and subordinate is a necessary condition for achieving integration of goals. Money is the great motivating force for the group members but not everything to stimulate the people to work by giving their 100%. What really makes them feel connected to a team or organization normally involves the questions like: What’s in it for me; Do I fit in; Can I make an impact, Does it mean anything; Can I express myself? There’s got to be s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    me sort of personal connection that motivates us to give their best.

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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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