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  • Digg It - Constructive Group Dynamics: How to Go from the S.N.I.P.P.Y. Syndrome to a C.L.E.A.R. V.I.E.W.

    If asked to look at your work calendar for the week, the odds are pretty good that you have a few if not several meetings already scheduled. Now, if asked how you feel about attending some of those meetings, 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
    odds are even better that you may either roll your eyes, groan or mutter something under your breath. Sound familiar so far? Okay, that was the easy part.

    Coming from a background of 20 years in the corporate
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    world, I can readily identify with attending a surplus of meetings. Additionally, I know all too well how employees come to "dread" going to meetings and clearly I fell into that category as well. But now in ret
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rospect, I've come to learn a few things, as we often do once we step back and reflect. After reading this article, you'll have a better understanding of what causes meetings to break down-- (S.N.I.P.P.Y) syndro
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    me and an alternative (C.L.E.A.R. V.I.E.W.).

    See if you can relate to any of the following statements:

    1. Look, I've invested a lot of time on this idea and
        if we can't move on it, I'll have wasted my
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    time.          Self-serving

    2. We never get anything done in this meeting, anyway.   Negativity

    3. We have to enforce this policy so people know right
        fr
    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
    om wrong.                                                          Insisting

    4. Can you believe how domineering she is in th
    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
    ese
        meetings--who hired her, anyway?                            Provoking

    5. Given our roles in the company, I think it's obvious
       that I shou
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ld make the final decision.                          Power driven

    6. If you would let others speak once in a while, it would
        be helpful.
    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
                                                               You statement

    As human beings, it's easy for all of us to fall into any of these behaviors from time to t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ime. What's more problematic however, is being unaware of our behavior and the effect we have on others in the workplace. As we know, like the "common cold," our attitudes can be contagious. The reason for this
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is something called the interaction cycle. The interaction cycle addresses how we interact with others and this impacts the quality of our relationships.

    The key components of the interaction cycle inclu
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    de:

    a. Values/Expectations/Mindset: these form our initial impressions.
    b. Selective Perception: a filtering function that only lets in what matches our initial impressions.
    c. Fe
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    elings: a range of negative to positive thoughts triggered by our perceptions.
    d. Action: our feelings ultimately influence our behaviors.
    e. Reaction: others respond to us by the w
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ay we act, so their behavior is in fact the result of what we send out.


    What we know then is that behavior breeds behavior. Now, it's starting to make some sense as to why we and others act as we do. But,
    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
    the more critical issue is figuring out what can be done.

    This brings us to a C.L.E.A.R. V.I.E.W. which is as follows:

    C = Concentrate on the listener
    L = Listen with the goal of und
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    erstanding
    E = Eliminate judgmental attitudes
    A = Actively listen (paraphrase what you believe someone said)
    R = Respect differences
    V = Value input offered by oth
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ers
    I = I messages (describing someone's behavior and its effect on you)
    E = Encourage participation from others
    W = Work towards agreement (build on what others say and the
    .

    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
    n add your        input)

    Wouldn't you rather have a C.L.E.A.R. V.I.E.W. than the S.N.I.P.P.Y. syndrome? Change is a gradual process; however with increased insight and the right tools, w
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e can all make a contribution towards constructive group dynamics. After all, why dread something that we could ultimately look forward to?

    Contact information: www.speech-matters.com; dale@speech-matters.com


    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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