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  • Main Subject - A Lack Of Accountability Is One Of Corporate America's Biggest Challenges

    One of the major challenges facing organizations today is to ensure accountability with its policies, procedures and philosophy. Over
    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
    the years, I have seen numerous instances where there are rules, standards, expectations and policies that are continuously ignored,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    sabotaged, and/or broken for any number of reasons by a variety of employees.

    As a manager, business owner or executive, ensuring t
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hat what you expect is actually happening on a consistent and routine basis is often a difficult, yet necessary, essential and effect
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ive task if you want to ensure that your organization operates with integrity and effectiveness.

    Some examples where there can be a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lack of accountability are:

    -favored employees
    -ego-centered management style
    -inconsistent discipline for infractions
    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

    -expecting behavior without taking the time or effort to inspect that the behavior is actually happening
    -inconsistent
    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
    treatment of new employees
    -inconsistent of family members who are employees
    -varying compensation plans
    -bonuses
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    that are given with no thought for performance

    There are numerous others. Why not ask yourself - Is there any area in my organizati
    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
    on or department where there is inconsistent accountability?

    You can’t manage your organization, department or group from behind you
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    r desk. You must circulate, be visible and get to know your people. This takes commitment and time, but will pay positive dividends
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    in the long run.

    Perceptions become reality in the minds of employees. It doesn’t matter if what they believe is true or not. If the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    y believe it in their minds, it is true.

    One of the best ways to determine the prevailing perceptions and attitudes throughout your
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    organization is to conduct an employee perception and attitude audit. To be truly accurate and effective, I recommend you retain an o
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    utside organization to conduct it. It should also be confidential. The employees must feel free to share reality without the fear 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
    retribution or punishment for delivering bad news.

    There are four premises for your consideration when it comes to accountability.

    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    One, expecting different results from repeated behavior is a mild form of insanity.

    Two, you get the behavior you reward in your org
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    anization. If you want to change behavior, you must change the reward system that is in place.

    Three, all culture flows top-down. Yo
    .

    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
    u can’t change an organization from the bottom-up.

    Four, when there is inconsistent accountability there will be inconsistent perfor
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    mance.

    If your organization lacks accountability I will guarantee that you have some morale challenges. Ignore these to your peril.


    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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