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    We have all attended meetings that were boring, mindless and profoundly ineffective. Meetings don’t have to
    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
    be a waste of time. Rather, they can be productive if the leader or chairperson practices these five strate
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    gies and gets down to the business of running the meeting instead of being run by it. People will then leave
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    the meeting with smiles, not frowns on their faces.

    Introductions.
    If people don’t know each
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    other, allow participants about 30 seconds to introduce themselves to the group. You can also have a quick p
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rogress update to allow everyone air time in the beginning of the meeting.

    Ground rules.
    Have
    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
    participants agree on ground rules, or expectations for this particular meeting. These simple rules of 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
    road, not only set the standards, but also are gentle reminders to those who are taking a different road or
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    direction. Some examples are: “One conversation at a time,” or “We will come to consensus on these particul
    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
    ar issues,” or “What is said in this room, stays in this room.”

    Parking lot.
    When a non-agend
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    a issue threatens to take over the discussion, stop the meeting and write, with permission from the group, th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is new issue on a wall chart called unfinished business. By doing this you acknowledge the item but don’t ad
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    dress it immediately. Parking lot issues are discussed at the end of the meeting or at a later date.

    Que
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    stions.
    To structure an orderly discussion of each agenda item, ask questions that address these
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    facets of an issue: What are the facts? What are the pros and the cons? What other options are there? Whe
    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
    re should the decision be made...at the committee level or by the entire group? What might be the next steps
    ping new procedures for reviewing their safety, efficacy and quality.

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

    Breaks.
    People work better for longer periods of time when they are able to take short brea
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ks, no longer than 5 or 10 minutes. Breaks are a good time to get feedback on the progress of the meeting or
    .

    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
    talk with people who have been antagonistic, disruptive, or unusually silent. It’s better to take a break,
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    take the pulse, and regroup then to doggedly push on despite a sense that the meeting is getting out of hand.


    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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