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  • Useful Advices - The Formal Account Review

    Why Review?

    Obtaining continual feedback against a set of established criteria is vital if an or
    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
    ganisation is to retain its existing top clients and seek to improve its standing and the quality of its
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    service levels to them.

    There are at least seven benefits of regular feedback.

    • Feedback reve
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    als your customer’s current and future plans.

    • Seeing your business from your customer’s point of view
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    allows you to answer the question “would you do business with you?” - if not why not?

    • Feedback allows
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    you to tailor your service levels so that you enjoy maximum customer satisfaction at a minimum cost.

    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
    If you don’t ask you’ll never know how you are doing until it’s too late! Feedback is magnified by the
    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
    ice berg factor’ making it more critical than it originally appears.

    • Feedback can reveal what your co
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    mpetition are doing helping you to be a consistently strong contender.

    • Gaining a reputation for wanti
    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
    ng to hear feedback can actually make money for you.

    How Often?

    This Will depend entirely On th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    importance of the account and revenue levels being achieved - or anticipated.

    Assessing The Feedbac
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    k You Receive:

    If the feedback you have been receiving to-date has not been useful, ask yourself th
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e following questions:

    • Do I ask enough questions?

    • Do I ask the right questions?

    • Do I communicat
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e effectively about why I am asking the questions?

    • Do I ask the right people?

    • Do I know how to use
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the data I collect?

    • Am organised to respond to the information?

    • Do I value and trust the informati
    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
    on I receive?

    What Do You Do With The Results?

    Collate & assess

    Communicate findings upwards &
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    sideways

    Act on vital issues

    Feed back remedial actions

    Confirm satisfactory resolve

    Remember,Th
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Account Review Process:

    • Is a non-threatening meeting.

    • It is a fact finding session not a sale
    .

    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
    s event in the short term. But

    • It is highly likely, that during this meeting you will uncover additio
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nal short, medium and long term opportunities.

    Copyright © 2006 Jonathan Farrington. All rights reserve


    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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