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    What is a team anyway?
    One of the most popular of business buzz concepts for many years now has been teamwork. We are always looking to be par
    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
    t of a team, seeking leaders who can develop teams and hunting for employees who aspire to be team players. Team is derived from the use of oxen or bulloc
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ks shackled together to create a focused, shared force, for transporting heavy materials. I like to think of a team in a different way. A team is made up
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    of individual stories; it is more than a group of people who have willingly set aside their egos; it is about not having or being a boss. A team is a coll
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ctive of individuals each of whom contributes to the working of the whole. A team is in fact a living entity.

    It’s up to you to decide if and when tea
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mwork is right!
    Teamwork is such a warm, fuzzy concept; how could we not like the idea? After all, everything is better when we work together and
    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
    promote togetherness. Right? Well, yes and then again, not always. We are bombarded with new and proven ideas to enhance, improve, reduce, grow, reshape,
    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
    replenish and create just about anything. In our personal lives we can readily accept or dismiss these notions. In business however, we tend to view new
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    deas as part of the masses. Maybe we’re concerned we’ll appear different from the main-stream or the competition. Whatever the reason, in business we are
    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
    far more likely to implement concepts without consideration of our own unique circumstances. Though teamwork is a profoundly valuable concept, applying it
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    does not abide by the one size fits all approach. It requires some decision making on our part.

    Teamwork is most likely to succeed (and thus will be of
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    greatest value) when the task is complex and requires a variety of input and action; individual effort required to complete the task exceeds the break-eve
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    point; time does not preclude the effort needed to assemble and deploy a team; team members understand their roles and are willing participants. Perhaps
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the most critical teamwork success factors are that leadership understands and supports the team and the concept of teamwork, and that goals are clear and
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    resources are consistent with the achievement of goals. Teamwork is least likely to succeed (nor is it of considerable value) when time is of the essence
    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
    and outcomes and decisions are timely and hold serious consequences; the task is too simple and of course when the non-teamwork approach is working just
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ine. In those cases where the leadership is autocratic or the work environment is chaotic, teamwork may be of value, but it is unlikely it will succeed.

    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Teamwork is a great idea. All businesses require a certain amount of teamwork, it is essential. But it is not the answer for all situations. Whether or no
    .

    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
    t to employ teamwork in a particular situation requires consideration and an understanding of both the task and the team. Teamwork requires voluntary part
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    icipation; goals must be clear; resources must be adequate to achieve goals and above all leadership must be committed to the team, its’ efforts and goals


    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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