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    “To be an excellent leader, one must lead with values, engage and inspire others, communicate effective
    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
    ly, and drive to win”
    Nelson Fabian.

    Effective management is more then just a useful skill, this
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    is a genuine art. Among the traditional qualities and roles of an effective leader, Stephen F. Stefano
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nd Karol M. Wasylyshyn identified the three leadership essentials, which further have been allocated in
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    o the ‘ICE’ – model. These scholars preach integrity, courage, and empathy in the first place. Why woul
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    researchers be so preoccupied with these three distinct features? The reason is essentially rooted in
    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
    he fact, that they realize how important image of an organization is for overall corporate well-being.
    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

    Image of an organization is essential in contemporary highly competitive market, where intangible asse
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s such as employees, reputation, and managerial skills are being valued more then the physical assets a
    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
    company owns on a balance sheet. Favorable image of an organization is also essential for its employees
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Janet M. Dukerich and Jane E. Dutton established a positive correlation between corporate image and in
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ernal health: negative personnel outcome is most likely to occur in organizations with poor reputation.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    Negative press of external environmental indirectly hurts its’ employees and directly company’s revenue
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    .

    Going even further then this, members of an organization tend to identify themselves with the corpor
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ation they are employed with. ‘Organizational identification’ is a form of psychological attachment tha
    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
    is experienced by members of a company who “adopt the defining characteristics of the organization as
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    efining characteristics for themselves.” One cannot expect organizational commitment and high productiv
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ty from employees, who have low self esteem and job satisfaction. Effective communication, stimulation
    .

    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
    f feedback, role model leadership that emphasizes integrity, courage, and empathy is the solution that
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    stablishes effective workplace relationships and at the same time creates positive organizational image


    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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