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    Recent studies have shown that industrial supervisors are working at less than 60% of their potential. Basic management skills training is guaranteed to change all this and at such little cost.

    Introduction

    There is no doubt that the
    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
    single most important aspect of a manager's job is the management of people. Of course, a supervisor must manage resources other than people. However, none of the other resources compare in importance to PEOPLE. The challenge to manage people effective is
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    nquestionably the greatest of all the challenges that face all managers.

    The problem with people

    It is estimated that there are over 6 billion human beings presently living on our planet and there are not two of us who are exactly alike. In other
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ords every one us is unique. One of the greatest mysteries has been, and still is, to fully understand how we work. It has obsessed scientists and the great thinkers since the beginning of mankind. Our progress has been minimal and maybe we will never know.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    A simplistic way for us to understand this complex issue is to consider a human like an onion with many layers. For example:

    1. Hereditary traits

    These are our genetic strings (DNA) that are passed down from generation to generation.

    2. Per
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sonal values

    These are created when we are children and are heavily influenced by our parents, etc.

    3. Attitudes and beliefs

    These are influenced by your personal values. It is what you think about things, situations and people. For example,
    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 may enjoy romantic music but dislike noisy people.


    4. Feelings

    Feelings follow attitudes and beliefs. For example, you feel good when you hear romantic music.

    5. Behavior

    This is directly related to your feelings. For example, romanti
    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
    music makes you smile, and people shouting makes you react angrily. One of the important challenges for the great thinkers has been to determine to what extent can the features of each layer be changed or manipulated. This single study area has proved to
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    be minefield of differing views that has resulted in enough books to fill many warehouses.

    For our purposes, we will assume that once someone has reached working age then he has unchangeable values, attitudes and feelings. In consequence, the only layer th
    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
    at we can work with as a manager is the final layer – our BEHAVIOR.

    However, it is important to understand how behavior has been influenced by the other inner layers.

    Now that scientists have defined human DNA it is possible that future mankind can develo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the perfect manager and then clone millions. However, in the meantime you will need this training manual!

    The final factor in our simple equation is EMOTION, which has a profound effect on our behavior. It stimulates our love and caring behavior but also
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nvokes violence and cruelty.

    Statistic analysis

    A lot of work was done in the 1960's to evaluate what really motivated workers. The responses of thousands of workers were tabulated and ranked in order of motivational influence. Not only did these s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    udies solidly support the basic theory but an unexpected phenomenon appeared.

    Although the relative rankings were consistent, there was always large gap between the top six factors and all the others.

    These statistics are quite remarkable and have never b
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    een seriously contested. However, it is very important to realize that the above list is not based on importance because the low scorers are high potential de-motivators if not at acceptable levels.

    Another important factor is that many of the early studie
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and the resulting statistics concentrated on what made people feel good and maintained morale. This has now become more objective with more emphasis on what motivates people to be more productive.

    What is leadership?

    It is a natural requirement of
    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
    human beings, like most other animal groups, to have leaders. There are many excellent wildlife films that show the dramatic and tragic process of leadership challenges in the animal kingdom.

    In caveman days we probably did much the same. Although the grou
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    was not directly involved in these struggles they obviously supported the outcome. When mankind developed from being hunters to being predominantly farmers the leader role became more sophisticated and different qualities were required.

    The Holy Grail
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    of management

    Throughout the history of management science there has been an unrelenting quest to find the holy grail of management success - a one best leadership style. As a result several main theories have emerged: trait theory, behavior theory, X
    .

    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
    Y-Z theory and contingency theory.

    The toolbox style

    I like to imagine all the theories like a toolbox where some jobs need a delicate instrument but others a heavy hammer. The choice is dictated by the job you have to do and your knowledge and sk
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ll. The tools that you have and choose and the way that you use them will determine the success of the work, and management is exactly the same. Let's look at the toolbox that you could have available if you choose to put them together and learn to use them


    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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