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    Training in its broadest sense is the provision of information to allow someone to carry out an old task better or to learn to perform a new task.
    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
    Yet training is often seen as an extra cost and therefore affecting the bottom line. When the business environment is difficult it can be one of th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    first costs to be cut.

    There is no denying that it does cost time and money to train people but it can cost far more when people are untrained. M
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    uch more time can be wasted showing people tasks that could have been learnt through some form of instruction.

    I can understand this resistance to
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    providing training in terms of cost. Even in larger companies the risk that people will jump ship after specialised training is always there. What
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ’s more once people leave education they can often become resistant to learning, beyond basic tasks required of them in their work environment. Oft
    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
    n it becomes the responsibility of the employers to determine how and when employees get training. A multinational I worked with used to sit down w
    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
    ith its employees every year and ask them about their training needs for the following year. More often than not it was a list of “approved courses
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    .

    This in part is where the problem lies. Employees can often see no benefit beyond a day out because they are not expected to. As a result it can
    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
    be easy to fill a one day course, when it’s a day out and you get paid for it. The employer fulfils their obligation and the employee gets trainin
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    . Unfortunately this can also mean people attending courses unsuited to them, which will never benefit them or their organisation. A large organisa
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tion, I know of, had telephonists signing up to financial spreadsheet courses simply because they were free.

    The problem is not with an organisati
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n selecting the wrong training courses, but with the fact that training ends up as one of those things talked about once a year. Either that or it’
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s an emailed list of courses for people to sign up to. In my own case, over time the company recognised this and became more proactive in trying to
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    identify more appropriate training.

    This is the nub of the problem, appropriate training. It is essential that they do what they are supposed to
    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
    do. It is also important to determine whether a course is even the right choice. After all there are a number of other ways people can learn. Some
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    f these do not include the need for a formal training course.

    Yet what organisations can sometimes overlook is the potential within. It is fair to
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    say that it is not as easy to quantify the expertise of an employee as against a professional trainer. It does not however mean that the expertise
    .

    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
    is necessarily less valuable. There are likely to be people who already have knowledge and have already been trained. So why not use them?

    In the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    next article I’ll look at ways that businesses can use to provide training programmes that allows them to use the expertise within the organisation


    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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