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  • Advice You - Career Advice: Never Let Your Boss Be Surprised By Bad News

    There is only one thing worse than delivering bad news to your boss. That is not raising the red flag when you know trouble is brewing, because it is a cardinal sin
    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
    to let your boss be surprised.

    No organization escapes the negatives forever. Budgets are not met. Deliveries are late. Machines don't work. People are caught with
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    their hands in the cookie jar.

    It is important to your career success to learn how to deliver ill tidings, as well as how to receive them.

    There are at least four
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    major things wrong with failing to blow the whistle when stuff hits the fan.

    First, ignoring bad stuff won't make it go away. It's bound to surface sooner or later,
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    probably at the worst possible time.

    Second, most problems can be fixed, wholly or in part, if addressed soon enough.

    Third, left unattended, most problems simply
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    get bigger and more difficult with time.

    Fourth, when you fail to report the bad news, you are leaving your boss vulnerable to being blindsided with a problem and
    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
    the accusation from his boss that he doesn't have control of his organization.

    Forget any notion that you may be a hero when you have to carry the problems to your
    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
    boss, no matter who’s at fault. Chances are you will take some bruises; whistleblowers are not popular. In ancient times, kings cut off the heads of messengers who b
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    rought bad news.

    Five Steps To Defuse The Situation

    There is really no easy way to report disappoints and shortfalls; however, you can take five steps to help defu
    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
    se the situations and ease the pain.

    1. Have all of the facts in hand. Report them succinctly; no dodging and ducking.

    2 Be patient; let the boss vent his or her a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ger and frustration.

    3 Offer a solution, or at least some way to cut the losses.

    4 Don't be defensive. If you are solely to blame, take the heat yourself; don't tr
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    y to lay it off on others. However, if a group of which you are a part is at fault be sure you report in the "we" mode. Try to depersonalize the matter as much as po
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ssible.

    5 Be sure to make a practice of reporting good news, too. Avoid being identified as one who always bears ill tidings.

    How To Receive Bad News

    Just as it i
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s important to quickly and accurately report bad news, it is necessary to know how to handle the storm warnings that are reported to you. These four steps will help.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen


    1. Stay calm and collected when an associate reports bad news to you. If you have a reputation of blowing up when such reports are made, you discourage the flow 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
    information that is necessary to function as a leader.

    2. Don’t go off half-cocked. Gather all the facts: who, what, when, where, why? Define the locale, type and
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    extent of the problem as quickly as possible. Assess the damage. And double-check your information.

    3. Initiate damage control ASAP.

    4. Report the situation to you
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r boss in the same fashion as you expect to be reported to. If you have been able to clear up the problem, report it anyway. Get credit for handling the matter witho
    .

    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
    ut taking up his time.

    If you have not been able to eliminate the problem, explain the steps you have already taken to prevent further damage, along with your recom
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    mendations for getting rid of the cause of the problem.

    Hopefully, you are working for an organization where the messenger gets shot only if he's late with the news


    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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