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    Action learning provides a structured approach to making progress on difficult and sometimes emotive issues. Taking part in an action learnin
    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
    g set can help improve skills vital to leading a business forward, namely:

    Being objective and making decisions

    Improving listening and que
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tioning

    Creating the climate for purposeful discussion

    An action learning set normally numbers between 5 and 7, and at the start is facilit
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ated to give the group a good foundation. Each member of the group gets a period of time to explain their issue, and then gets questioned by
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    he rest of the group. Each member of the group can take a turn. A good set has trust between the members, a good set of ground rules that hav
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    been adopted, and individuals learn to ask the right questions so that another member of the group can make good progress.

    They probably le
    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
    arn this from each other.

    Action research is quite similar. Using similar questioning and listening techniques it may be possible to make pr
    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
    gress on an issue that has been difficult to resolve. Again the key is asking the right question, and exposing yourself to an answer that may
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    be uncomfortable.

    Within action learning having the right sort of climate is important. Trust is key to this. For instance if you were havi
    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
    ng a meeting and the following signals were given, how would you feel?

    1.‘I’m judging you’

    2.‘I’m in charge’

    3.‘I can manipulate you’

    4.‘
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    don’t give a damn about you’

    5.‘I’m superior to you’

    6.‘My mind is made up. Nothing you can say will alter it’

    (Gibb, J, (1961). Defensiv
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    communication. Journal of Communication, 11, 141-148)

    One of the problems of considering joining an action learning group is that it could
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    be uncomfortable and public, at least with the other group members. Another Gibb (AA Gib, Enterprise Culture 1987), suggested that entreprene
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rs focus on active learning and the opportunity (amongst other factors). An interesting debate is whether entrepreneurs have learnt these ski
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ls through experience, or possess them naturally as they are inquisitive.

    If this is so - that suggests that good business people are able t
    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
    o create the climate in which they can learn from others.

    Many small business owners find creating the right environment quite difficult, es
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ecially if it might involve some aspect of change on their behalf. This manifests itself in frustration, anger, submissiveness and fails to c
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    eate the right climate. This in turn may expose them to making comfortable decisions and not succeeding in the way they would have liked.

    Al
    .

    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
    though many action learning sets are set up with the aid of a facilitator, the intention is for a set to be self sustaining. With no outside
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    elp.

    This makes them very cheap, and an environment where you can learn some of the fundamental skills needed to be an effective businessman


    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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