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  • Useful Advices - Do You Know What's Working And What Isn't?

    I will guarantee you that every manager can improve thier skills in some area. Many managers focus only on what
    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
    they are doing wrong while others only focus on what they are doing right. The problem with either strategy is cl
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ar...

    Three of the questions I often ask the participants in my seminars are:

    1. What are you doing in your lif
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    , career or business that is working?
    2. What are you doing in these areas that is not working?
    3. What
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    did you used to do in these areas that worked – that you have stopped doing?

    These three critical questions can
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    eep you traveling in the right direction in all areas of your life if you will ask them often enough and pay clos
    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
    attention to the answers you get. I ask myself these three questions at the end of every month and the end of ev
    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
    ry year.

    The purpose of this exercise is to ensure I am:

    1.Focusing on the right things in the right way.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    .Letting go of stuff that isn’t working.
    3.Re-evaluating my career, business and life from past, as well as
    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
    uture, orientation.
    4.Stretching myself into new areas of development.
    5.Experimenting with new strateg
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    es, attitudes, philosophies, feelings and skills.

    Many people are stuck in old ways of thinking, doing and belie
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ving that just are not working for them anymore. Many managers, executives and business owners are bogged down in
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    products, policies and approaches that just are not working anymore. Why? Fear? Comfort? Indecision? Arrogance? I
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    norance? Ego? Politics?

    What are you holding on to?

    1.A product that has outlived its purpose or usefulness? <
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    r> 2.An unproductive or negative employee that is sabotaging the productivity of a department or the entire org
    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
    nization?
    3.A policy that should have been changed months or years ago?
    4.An attitude or prejudice t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    at is getting in the way of your personal success?
    5.A management style that is counterproductive?
    6.A
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    rocedure that is confusing or counter productive?
    7.A habit pattern that is keeping you from improved effect
    .

    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
    veness?

    Why not spend some time on these 7 questions to see if you can uncover any areas that need modification
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r abandonment. If you feel really daring, why not put these questions to some of your employees or direct reports


    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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