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  • Digg It - What is Managing Up?

    "Managing up" is all about establishing good relationships with the leaders above y
    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
    ou, so you can further your goals and the goals of your group. People deal best wit
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    h those they like, or at least respect. Overall, you will need to become visible to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    these people, understand their goals and needs, and be able to express your needs
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    n terms that align with your manager's agenda and vision.

    "Managing up" also means
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    making it easy for your manager to manage you. This is accomplished by keeping lin
    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
    es of communication open and by making it easy for your manager to trust you and yo
    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
    ur word. Be specific in your requests. Give your manager(s) regular reminders. Be a
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    are of your manager's agendas (all of them) and his/her vision for the future. You
    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
    may have to ferret out your manager's hidden agendas, but the knowledge you gain wi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ll be invaluable in garnering your manager's support for your initiatives and proje
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    cts.

    Finally, don't bring your manager problems without bringing a range of possib
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e solutions. You will have more influence with your manager if you bring her/him we
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ll-conceived options from which to choose. Otherwise, your manager may begin to see
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    you as a complainer and a whiner. Your manager will begin to avoid you whenever po
    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
    ssible; s/he may even ignore some of your requests or assessments at a critical jun
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ture because you are seen as the person who always cries, 'Wolf!'

    Bottom line: Kee
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    p your interactions simple, direct, and regular (even when you don't want to); know
    .

    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
    your manager's agendas and vision and act accordingly; be a problem-solver, not a
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    whiner; and make it easy for your manager to trust and respect you. (Is that all?!?


    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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