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    Before you can start advising others how to get their act together, you need to ensure that you have got your act together. i.e. you need to walk the talk and set a good example. Now that you have a good idea of what supervisors need to do to be good supervisors, let us explore some basic qualities needed to make
    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
    a person a positive, capable, responsible, diligent person, whether he/she is a supervisor or not.

    "Being Proactive" is covered in this article; "Being Productive" will follow.

    Proactive Defined

    Proactive means that as human beings, we are responsible for our own lives, and are not led around blindly by other
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s. Our behavior is largely a function of our own decisions, rather than our conditions. We have the initiative and the drive to assume full responsibility for our own lives, and make things happen that should happen.

    Stephen Covey in The 7 Habits of Highly Effective People, (p.81-3) defines being Proactive/React
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ve in terms of Circles of Concern. We all have concerns.

    Proactive people deal almost exclusively with the area within which they have influence and can do something about. Their positive energy increases their Circle of Influence. Reactive people are concerned about everything and have little influence on anyt
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    hing. Their negative energy shrinks their Circle of Influence over time. As Covey puts it, "They focus their efforts in the Circle of Concern. They focus on the weaknesses of other people, the problems in the environment, and circumstances over which they have no control. Their focus results in blaming and accusi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    g attitudes, reactive language, and increased feelings of victimization."

    Responsibility

    Look at the word responsibility: response—ability: the ability to choose our response. Highly proactive people recognize that responsibility. They do not blame circumstances, bad luck, other people (e.g. the boss, the wife,
    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
    the children), etc. They accept their circumstances and their ability to respond to it (i.e. its their responsibility). Is there any surprise that proactive people are also good leaders?

    Reactive people, on the other hand, blame every thing but themselves for their circumstances. Eleanor Roosevelt said “No one
    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
    an hurt you without your consent.” Mahatma Gandhi, the founder of modern day India, put it another way: “They cannot take away our self respect if we do not give it to them.” For this reason Nelson Mandela is one of the great people of our time. For 27 years he remained in prison. He retained his self-respect thr
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    oughout his sentence and in time became respected even by the most brutal prison warden. When he finally left prison an old man he remained positive, strong and upbeat and never once blamed those that put him in prison. If he had been bitter for 27 years, imagine what a miserable old man he would have become.

    Se
    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
    f-Image

    Basic to being proactive and, by inference, a good leader, is having a good self-image. That means, for example, feeling good about yourself, respecting yourself and your accomplishments, as well as recognizing your mistakes (we all make them) as opportunities for learning and improvement. Having a good
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    self-image is not easy if, over the years, your parents, your teachers and your bosses have told you how useless you were. But developing your self-image can be done even in difficult circumstances. Using positive thinking, proactive language and behavior as outlined below will definitely help you.

    Learning Ac
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tivity

    Write down a few things positive statements about yourself. Read them, memorize them and repeat them at least three times a day. Find a quiet place, shut your eyes and, in your mind, visualize yourself acting in a positive, proactive manner at work or home. Do this for fifteen minutes once a day.

    When y
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    u feel down, depressed, dejected, angry, take a few moments to think of (visualize) something or some place that is pleasant and calm. Then say to yourself some positive affirmations, such as "I have a lot to be thankful for." "I am a good person." "I know I can do this job well." Soon, you will be feeling positi
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ve and upbeat. Positive thinking does indeed work!

    If you look good, you will feel good. Make an effort to be well-groomed and dress smartly (that does not necessarily mean a 3-piece suit). You need to look the part of being a good, positive leader.

    Proactive Language

    The choice of words, phrases, sentences, q
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    estions, statements, etc. that people use to communicate with others or with themselves—their “language”— may be reactive or proactive. Many people who are not as effective or productive as they have the potential to be use, either unconsciously or consciously, language that is reactive. You, as a supervisor, mus
    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
    t consider very seriously your choice of daily language.

    Learning Activity

    Here is a little activity for you. Below are two lined columns, which you can replicate on another piece of paper, A and B. For each line, first write an example of reactive language in Column A; then turn it into a proactive example in
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Column B. One example has been given to get you started.

    A: Reactive B: Proactive

    My wife didn’t get my breakfast | I will make my own breakfast

    Here are some examples, first of reactive language—to be avoided—and then of proactive language:

    Reactive Language Proactive Language

    It's not my fault. What can I
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    do to improve the situation? I can't help it; I'm just like that. How can I learn to change my behaviour?

    They won't let me do …. I will convince them, with logic and examples, that this is the correct course to take. I don’t have time to do …. How can I schedule my time to do the job? She makes my life impos
    .

    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
    ible. What can I do to improve our relationship? My crew is driving me crazy. How can we work together as a team? He is really on my case. What can I do to resolve the problem? If only I won the Lottery, I could buy that house. I will plan and write goals to work towards so that I can buy a house.

    I am not go
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ing to get involved. What can I do to help out? orI can't help here, but I can refer you to someone who can.

    I am not very capable. There are many things that I am good at. I know my strengths and weaknesses. I am working to capitalize on my strengths and improve.

    What a mess! Let's work together to clean it up


    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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