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  • Useful Advices - Let's Form A Committee

    "Let's form a committee!" When you hear these words during a public meeting, a warning light should start flashing, for more often than not Parkinson's law may be coming into play. One of the many precepts from this law states that work expands so as to fill
    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
    the time available for its completion. It was first articulated by C. Northcote Parkinson, a British scholar, in the book "Parkinson's Law: The Pursuit of Progress," (London, John Murray, 1958). Based on extensive experience in the British Civil Service sys
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tem, his scientific observations noted, among other things, that as the British empire declined, the number of employees at the colonial office increased. Parkinson claimed this was caused by two forces: One, officials want to multiply subordinates, not riva
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ls; and two, officials make work for each other.

    Among many other things, his law is also used to refer to a derivative of the original law relating to computers; namely, data expands to fill the space available for storage (see Moore's Law).

    Verification
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    of this law is most readily found in government where bureaucrats usually want subordinates, but not competitors, to help with overwork. In the field of public administration in the United States, it has been widely observed that work tends to increase in im
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    portance and complexity in direct proportion with the time to be spent. Politicians and, frequently, taxpayers (the latter with at least an occasional sense of doubt) have assumed that an increased number of civil servants must be the result of an increased
    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
    amount of work to be performed.

    Here is an example, widely used by other writers, of how it works. Let's assume an individual contributor (for example, one who is part of the overhead structure) finds herself overworked. For this real or imagined overwork s
    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
    ituation, there are at least three solutions. First, she can simply quit, but this is not a likely outcome given the loss of relatively generous public sector benefits. Secondly, she might request that the work be divided with another employee, but this crea
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    tes an unwanted rival for promotion. Or thirdly, she might ask for the assistance of two subordinates thus adding to her importance. Assuming the third choice is the one taken, and it usually is, one can further assume that sooner or later one of these two s
    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
    ubordinates will also complain about overwork thus creating another round of employment. If you do the math, seven officials will eventually end up doing the work that one did before. To make matters even worse, the two subordinates may be nepotistic hires w
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ho in turn may hire other relatives or friends. This is precisely why there are those who are such staunch proponents of doing more with less.

    I recently heard one local selectman state that both the "Share the Road" signs (i.e., share with bicycles) and pr
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    omoted by the ever-so-righteous Rotarians, and the construction of two major rotaries (i.e.,roundabouts) on a local arterial parkway are important issues. The implication was that both were of equal importance. Surely he was not serious.....but he was! The s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ign issue should not even have been on the table. It was a classic example of where the amount of time given to an issue is so far out of proportion to its importance, it makes one wobble. In this connection, Parkinson not surprisingly laid down a dynamic th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    at said groups spend time on subjects in inverse proportion to the importance of the subject. The issue of rotaries on the aforementioned parkway is indeed important but hopefully will not lead to a study committee which may in turn lead to subcommittees. In
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    stead, the selectmen need to resolve this. Again, warning lights are beginning to flash, though ever so dimly.

    For a new and even more negative meaning regarding the wasteful practice of patronage, all one need do is take time to review the gross duplicatio
    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
    n of effort between the Massachusetts Turnpike and that state's Department of Transportation. Patronage is a phenomena which Parkinson perhaps did not fully take into account but most assuredly would make his eyes roll. Indeed. the public sector in Massachus
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    etts is an exemplar of Parkinson's law gone stark-raving mad. Maybe that's why Massachusetts is called a Commonwealth.

    So what say we form a committee to review rotaries or some other subject. Let's schedule meetings, lots of them. Let's analyze the results
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    of these meetings. Let's schedule more meetings to discuss the analyses. Now let's assign priorities and hire some people or "experts" to handle the tasks resulting from the priorities. The hires, of course, will attach great significance to their work and
    .

    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
    likely will attempt to expand it as far as possible. Their salaries will then go into a line item budget under a cost center entitled, "salaries." When this happens, Parkinson's law has set in and things are no longer a joke.

    "By expanding their 'work' to f
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ill the time available, and grabbing at every opportunity for advantage and self-aggrandizement, they've [Congressmen] made their world a better place. But is it their world, or ours? Has the expansion of work been a benefit to you?"

    Paul Hein Archives, 200


    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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