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  • Digg It - Managing Media Replication Projects

    The goals of every media replication and packaging project are:



    • Deliver your product to the end-user on time.

    • Use the most cost effective options possible to achieve the
    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
    project's business goals.

  • Deliver a pristine, high quality final product to the end-user.

    The first step to achieving these goals is to establish a budget and timeline tha
  • ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    meets all project requirements. The best way to ensure that timing and budgetary restraints are met is to involve all the pertinent players from the start. On many projects, the repl
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ication and packaging people are brought in too late to optimize the campaign's effectiveness. Too often decisions are made without the input of key participants in the process, result
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ng in a truncated replication and packaging timeline and less- than- optimal product costing more than it should.



    The participation of replication and packaging experts throug
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    out the process more effectively organizes your project. They can be particularly helpful in identifying opportunities for improving efficiency. In many cases, for example, key media pa
    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
    ckaging elements and the final media content development stages can be produced concurrently. Most importantly the early involvement of a seasoned media replication and packaging profe
    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
    sional can give the project more options and help avoid challenging situations before they occur.

    Organizing a Media Replication and Packaging Project

    There are steps to be tak
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    n and questions to be asked at the offset of all media replication projects. Working through each step ensures the most efficient process and highest quality results.

    • Estab
    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
    lish business goals - what are you trying to accomplish?



    • Sales or marketing?

    • Education?

    • Training?

    • Entertainment?



  • Identify your audience.

    <
  • ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    l>

  • Business executives?

  • Factory workers?

  • Teachers?

  • Senior citizens?

  • Children or adolescents?



  • Determine the final quantity.



    • H
  • ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    w many people does the campaign need to reach?

  • Decide how the final product can meet the business goals of the project.

  • Determine which delivery mechanism will be use
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    d to get final product to the end-user.



    • Are they being given out at a trade show?

    • Will they be sent in the mail?

  • Decide which media should be used - CD,
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    DVD, or VHS.



    • Will end-user view product on a computer or TV?

    • Does end-user have a DVD player or computer with DVD drive?

    • How much content is the on final prod
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ct? Can it fit on a CD?

  • Will there be video in the final product? Is it a talking head or full motion video? Is the sound quality important?

  • Assign a level of imp
  • 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
    ortance to the final product's design element.



    • Is the end-user required to view the media?

    • If not, will it take a powerful design element to persuade the end-user to
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    view the media?

  • Does the design need to be consistent with the company's established corporate palette?

  • Choose the kind of packaging that achieves both the delivery
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nd impact goals of the project.



    • Do collateral printed materials need to go in the packaging along with the media?

    • Will it benefit the project if a sample of the comp
    .

    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
    any's product is packaged with the final unit?

  • Identify the project's final budget.

  • Specify the action desired of your end-user after receiving the product.



      elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

      Companies that provide selfless information through particip
      > Is a Business Reply Card needed?

    • Should the return address on the packaging?

    • Should the URL and phone # be clearly visible on the packaging or media label?



  • 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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