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  • Just Other Articles - Career Advice - You've Been Passed Over, Now What?

    You sincerely believe you are the best qualified among the candidates for the promotion to manager of your department. You believe you deserve it. Your friends agree.

    But, wh
    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
    am! The rug has been pulled out from under you. The position you would have given an eyetooth for goes to someone else. Your ego is trampled. You are mad and disappointed.
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    You want to march in, tell the boss where to go and leave the place.

    But hold on. Apply a little common sense before you go off the deep end. You've still got your job and 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.

    is is a good time to consider where you want to go with your career. Force your chin up. Congratulate the winner right away. This will be painful, but it actually will help
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    you regain your balance. Moreover, it will strengthen your position as a team player.

    This is a dangerous time for you. Simmer awhile before you act. Brood and grieve a li
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tle in private if it makes you feel better. Reject bitterness; it's poison. Look beyond your ego. Sure, your feelings have been bruised. No need to be ashamed of that.

    But
    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
    really has all of this been damaging to your long-term career goals?

    Time To Be Objective

    Your greatest need at this is to understand the "why" behind the situation.

    Start
    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
    ith a discussion with your boss. Remember, you are there to gain information, not to argue your case. Don’t beat around the bush. Admit you are sorely disappointed. Assure yo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ur boss you are not bitter or resentful. Pledge 100 percent allegiance to the team. Admit, however, that you are concerned about what has happened and what it may mean for 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
    future.

    Focus on the critical questions about what happened and why. Has your past performance and your preparation for the next step been at least up to par? Are you as qua
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lified or better than the competitors? What might you have done to improve your chances to win a promotion?

    Did you miss some signals from your boss, telling you to improve
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    you performance? Were there any bonafide indicators saying you were a candidate for promotion? Or have you been engaged in wishful thinking?

    What qualification did you not h
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ve? Will there be other chances to win promotions? What can you do to improve your qualifications for advancement?

    You must listen as you have never listened before to both
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    what is said as well as what is implied between the lines. Be aware that you will be strongly inclined to hear the best side of the story. And don’t forget, it is the most n
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    tural thing in the world for the boss to try to soften the message. Besides, if you have been doing an adequate job in your present slot he will want to keep you around. Or he
    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
    simply may be testing you for a bigger assignment.

    Now you are ready to get to the bottom-line. Review all of the facts. Do you agree with what you learned from your review
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ith the boss? Have you been treated fairly? Were there legitimate reasons you were passed over? Do you care enough to take the necessary action to win the next time? Do you
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    have a reasonably secure future in the organization? Can you be happy where you are? What are the acceptable alternatives? Do you want to find a more rewarding situation else
    .

    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
    here?

    Being passed over may be a blessing, although if it is, it appears to be quite will disguised. You have an opportunity to gain a more realistic view of where you are, w
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    here you want to go and what you have to do to get there. Or you may conclude you are satisfied with your present position, so you can relax with more time to smell the roses


    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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