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    Did you know that Bird Flu Pandemic could in fact put your company out of business? Think about it? Employees can
    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
    not come to work if they are sick, as they could infect the rest of your team. Meanwhile some can work from home,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    but not all; do you have a plan? Why not; are you simply going to wait until it is too late?

    Worse off what abo
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    t your Suppliers are they ready? Without them you cannot do business anyway? Can you imagine the headaches and yo
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ur business being shut down completely? We have come up with a supplier questionnaire and here is a sample to sur
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ey your suppliers to see if they are ready?

    Your company name:

    Address:

    Contact name:

    Phone number:

    e-mail a
    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
    ddress:

    Supplier name:

    Address:

    Products/services purchased/planned to purchase:

    e-mail address:

    General Bir
    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
    d Flu Pandemic Planning

    1. Has your company established a Bird Flu Pandemic readiness program? Yes / No

    2. Do y
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    u have resources and budget committed to BIRD FLU PANDEMIC readiness? Yes / No

    3. Have you reviewed all projects
    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
    and equipment purchases for BIRD FLU PANDEMIC? Yes / No

    4. Are you confident you can supply my company with th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    goods and services we already purchase or plan to purchase from you? Yes / No

    Distribution

    1. Do you have pla
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ns and vendors who can guarantee distribution of your products to us in the event of this coming Bird Flu Pandemi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    c? Yes / No Have you considered and planned for Distribution planning, Distribution operations and Shipping

    2
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    Have the manufacturers of both the your products components and service vendors figured out how they can guarant
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ee that they are BIRD FLU PANDEMIC ready? Yes / No

    3. If you have determined they are not BIRD FLU PANDEMIC read
    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
    , what will you do to guarantee you will be able to perform as a supplier to us?

    Your Suppliers

    1. Have you eva
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    luated all of your suppliers for their BIRD FLU PANDEMIC readiness? Yes / No

    2. Are you tracking and managing
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    their situations and impacts on you? Yes / No

    ------ ------- --------- ---------

    You will of course need to mo
    .

    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
    ify this form to fit your company, but indeed it does give you a head start and do not be surprised if other comp
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    anies which are customers of your company to ask for the same. So consider all this before it is too late in 2006


    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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