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    We've all been there, right? The familiar dread that seeps into your subconscious on Sunday nights when you have to return to "You know where" in the morning! Yes,
    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
    it is the familiar angst of returning either to a dead-end job or dealing with a toxic boss. Has your relationship with your boss taken a turn for the worse? Do y
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ou sense that the tension in the air when you interact with your boss? Relax, it's time to turn things around and it starts with YOU.

    We need to evaluate how and w
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hen things turned sour. Grab a paper and a pen and be honest with yourself. Was their a miscommunication? or perhaps confrontation to cause the issues at work? o
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    is your boss simply difficult to work with? We'll address both scenarios in this article.

    Miscommunication/confrontations: Determine what the issue is and write
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    it down on the pad. What was your boss's reaction and what was your reaction to the issue? Time for honesty here if you truly want to work things out. Make a list
    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
    of anything you think that might have contributed to the misfire in communication.

    SCHEDULE A ONE-ON-ONE MEETING WITH YOUR BOSS: Choose a day and time where 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
    oss will not be rushed for time or have meetings most of the day. You want the meeting to be as relaxed as possible. Put your best smile on and request to meet wit
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    h your boss.

    BEFORE THE MEETING: Organize your notes. Jot down any ideas or issues you want to clarify and practice speaking your points. DO NOT USE THE FOLLOWIN
    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
    G PHRASES! YOU ALWAYS, YOU NEVER. This only enflames the situation by setting an accusatory tone. You want to heal this relationship, not make it worse, right?

    D
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    RING THE MEETING: Thank your boss for meeting with you. Tell him/her why you wanted to meet with them. A sample opener might be, "First of all, I would like to th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ank you for meeting with me. The reason I wanted to meet with you is that I am feeling that there is some tension between us due to "the issue". Do you feel the s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ame? Have your pad and pen ready to jot notes as your boss speaks. Always speak in a friendly tone and listen to what they have to say. If your boss states that t
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    here is a problem between the two of you, ask them the following: "What can I do to improve this situation?".

    Once your boss details what you can do, make sure you
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    understand their position and ask for a follow- up meeting to measure your progress. This shows your boss you are willing to take ownership of the solution.

    AFTER
    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
    THE MEETING: Send an email to your boss thanking them for setting time aside for meeting with you. Include the bullet points you each discussed and that you both a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    greed that a follow-up meeting would be scheduled to see if progress is being made. Ask for your boss to clarify if any points are inaccurate that you just detailed
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Save your email and your boss's response if any.

    Now, you may be saying to yourself, "But, my boss is the one to blame! Not me!". That may be true. If the relat
    .

    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
    ionship with your boss is due to a larger, more involved issue, you may need to involve Human Resources to mediate. If that is the case, you have proof from your e
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    mail that you tried your best to address the problem in a professional and conciliatory manner. This will always work in your favor.

    Good luck and happy employment


    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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