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  • Main Subject - Warning! Meeting In Progress; May Be Hazardous To Your Career

    There ought to be a sign posted on every closed office and conference room door that reads: Warning! Meeting In Progress! May Be Hazardous To Your Career.

    Because most meetings burn up a lot of resources
    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
    that could be spent on useful purposes. These sessions are either not necessary, or they are so poorly organized and conducted that they achieve only a fraction of their purpose.

    You’d think any thi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ng that dangerous would be drastically reduced if not eradicated. Not so, the number of meetings appears to be proliferating.

    How Much Are Meetings Costing Your Company?

    How much of a problem are meet
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ings for you and your employer?

    Is the time spent in meetings causing you to be late in turning out your work? Are you going in at night and on weekends to make up for time spent at meetings?

    Are mee
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tings worth what they are costing your company?

    One company mounted a large digital meter in its conference room. The total cost per hour for each person (salary and benefits) attending a meeting was
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    fed into a computer, which in turn, divided the sum into cost per minute. The device was activated when more than one person arrived for the meeting and was shut off when the last person left the r
    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
    oom. The total dollar cost of the meeting was added up, minute by minute, on a screen for all to see. The number and length of meetings were soon sharply reduced.

    You can make the same calculation
    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
    for your firm with a scratch pad and pencil. I guarantee you will be surprised at the cost.

    The Reasons Meetings Fall Short

    Meetings fail or fall short of their objective for a variety of reasons.

    T
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    he most frequent cause is that no one – not even the chairman – is in charge. This usually means a clear purpose for the meeting has not been established. An agenda has not been drawn. Participants
    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
    can’t prepare in advance. So there is a lot of wandering around.

    The door is left wide open for discussion of any and everything, other than the matter at hand. This condition also allows the showbo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ts to get their time on stage.

    Some people may even prolong a meeting because they have nothing better to do. Meetings are often called to achieve something a meeting cannot accomplish, such as draf
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ting a statement. Meeting may flop because participants have not done their homework.

    What can you do to control the meeting beasts and make them yield better results for your organization?

    First,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    don't hold a meeting unless it is absolutely necessary. It has been estimated that as much as one-third of the subject matter taken up at meetings is not appropriate for that venue and could have bee
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n handled by other means – the telephone, e-mail or a stand-up discussion in the hallway.

    Second, if a meeting is necessary, the chances for success are enhanced greatly by a good chairman, one who w
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ill be fair, yet relentlessly firm and fully in control of the proceedings. Contrary to popular belief, good meetings are not freewheeling exercises in utopian democracy. The best ones are run by be
    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
    nevolent dictators.

    Five Steps To Successful Meetings

    The truly effective chairman will take five steps to expedite the conference. He or she will:

    1. Clearly state the purpose of the meeting and set
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    a time limit; provide an agenda and clearly state the issue(s) to be discussed. This will be done in writing. In advance.

    2. Be sure all points of view are given a respectful hearing, but firmly cut
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    off discussions that stray from the purpose of the meeting or are out of sequence.

    3. Ensure there is only one discussion going on at a time.

    4. Make certain the meeting comes to some recognized con
    .

    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
    clusion, with "next steps" understood and agreed upon.

    5. Send out minutes of the meeting within 24 hours. These minutes will record decisions made and assign follow-up duties.

    It is a tall order to
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    bring the meeting beast under control. It has been around and growing forever. But it is worth the effort in terms of cutting back on frayed nerves and energy taken away from more productive pursuits


    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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