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  • E-Folder - Dealing with a Verbal Bully During an Informal Discussion

    Anyone who has been in the concrete jungle for more than five minutes soon learns two lessons fast:

    • Many very impo
    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
    rtant decisions are made during informal meetings e.g. passage meetings, spur of the minute meetings, sudden meetings in of
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    fices or even the canteen etc.
  • Verbal bullies thrive during informal meetings.


  • Have you ever faced a sit
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    uation where you were trying to make your point during one of these informal discussions and a verbal bully constantly inte
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rrupted you? Usually it would have happened at a meeting of two or more people (verbal bullies love an audience). I am sure
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    you have, most of us have been there. It is very frustrating and annoying, especially if the meeting ended without you hav
    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
    ing had a chance to make your point.

    But there is hope. There is a way to deal with the verbal bully.

    And remember: A for
    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
    mal meeting with weak chairperson soon turns into an informal meeting with the verbal bully ruling the roost and the chairp
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    erson.

    Here is a method of dealing with the interrupting bully effectively

    Step 1

    As t
    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
    he verbal bully interrupts, do not take your eyes off the person you are addressing and continue to address that person in
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    a calm voice. You must not make eye contact with the interrupting bully.

    If Step 1 does not stop the bully, proceed to Ste
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    p 2.

    Step 2

    Simply raise the volume of your voice, making sure that you keep your eyes on the person you
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    are addressing. You must not make eye contact with the interrupting bully.

    If Step 2 does not stop the bully, proceed to
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    Step 3.

    Step 3

    Keep your eye on the person you are addressing, raise your voice slightly, and raise your
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    hand in a stop sign indicating to the interrupting bully to stop speaking.

    At this stage, most interrupting bullies will
    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
    keep quiet. However, if the bully continues to interrupt, proceed to Step 4.

    Step 4

    Stop speaking to the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    person you are addressing. Turn and face the interrupting bully face to face. Look the interrupting bully, directly in the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    eyes, and say: "Would you mind keeping quiet until I finish?" This will silence almost all verbal bullies. When
    .

    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
    the verbal bully keeps quiet say "thank you" and continue to calmly make your point.

    This strategy usually works
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    . Your self-respect will be intact and you will gain the respect of the group and perhaps even the verbal bully.

    Good luck


    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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