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  • References - Take Your Time Seriously

    So many people seem to feel that their lives are rushing by at an ever-increasing manic speed! Are you one of these? Does it seem as though you are caught in a relentless spiral of time problems? What is stopping you taking more control of your time and your l
    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
    ife? It is an interesting idea to list the "reasons" - and then consider them individually. Challenge yourself. If you had to change that, how would you? The reality is that the answers to getting out of this time turmoil lie with you!

    Working with people at all
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    levels, in a wide range of organisations over a number of years, it strikes me that the root of the problem is that so many of us do not take time seriously! We overlook the basic fact that time is a resource! To borrow a quote, "The supply of time is totally
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    inelastic. Time is perishable and cannot be stored. Time is totally irreplaceable and cannot be stored." Most of us forget to treat time as a perishable resource and appear to take it for granted.

    A friend of mine lent me a book, which may be out of print b
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    y now, "The Art of Time" by J-L Servan-Schreiber. He refers to the concept of time mastery, which I love! If we want to move beyond the reactive, rushed lifestyle many of us are living we need to develop time mastery! The truth is we cannot actually master time,
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    hat we can do is master what we do with our time. To do this we have to begin to value our time as a precious resource. Recgnise that every day which passes is one which has gone. We cannot get it back and rerun it!

    Servan-Schreiber has a simple approach, which
    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
    believed in even before discovering his book!

    We can only start to take control of our time when:

    • we accept that we choose what we do with it
    • we know what we want to do with it
    • we start to be proactive with our use of time
    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
    This first point is key. We have to take more ownership for what we do with our time. We are making choices - albeit often at an unconscious level! If we do not value our time highly we will allow others to take control of it. This ca
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    then lead to resentment as we feel put upon! Another aspect of this can be a contribution to feeling pressure mounting to becoming stressful.

    There are many reasons why we grow into adults who do not think about choice when using time. Upbringing can have a par
    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
    to play. A wish to get on with others, or to be seen to be helpful are understandable contributors. These are very true if we do not take our own time seriously! We have to value it, both at work and in our personal lives.

    Another challenge which many of us fac
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    is deciding what we want to do with our time. If we do not have priorities among our tasks, or outcomes we want or need to achieve, we have no reason to value our time. Identifying some key priorities of things to be done, or setting some goals will help. This g
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ives us a chance to work towards things, and to achieve them which can make us realise that our time is important! By having this focus, we can feel we have more control with our time.

    Having things we want to achieve means we can plan to work towards them. In t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    rn, this encourages us to be more proactive. This puts us in more control and allows us to feel positive about what we are doing, which means less pressure and less stress!

    Taking time seriously will not just happen. We have to make it happen by our actions and,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    more importantly, by our thoughts and wishes. The behaviours required to manage our time differently are comparatively easy to learn and apply. They are mainly common sense! What stops most of us using them are the messages and thoughts running in our head! Know
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    what really matters to us. Identify our values. When we spend our time in a way which is meeting our values we are happier and more motivated. When we feel as though we are being pulled or pushed into spending time in ways which are not meeting our values - the o
    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
    posite occurs.

    This is easy to put on paper and to talk about. For most of us the challenge is to apply it in our day to day lives! We have to face up to the fact we are responsible for our own time. Once we can accept this, we are on the journey to taking time
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eriously and living the life we want.

    To achieve this, we can take some simple steps. (Well, simple on the face of it - hard in that they make us face a reality about where the ultimate choices lie!)

    • Analyse what we do with our time. Keep a simple time
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    log of what we do each day for a week or two. This usually provides some interesting insights!
    • Recognise our own bad habits around using time. What do we put off? What do we spend a lot of time on because we enjoy it?
    • Identif
    .

    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
    who and what distracts us or interferes with our time.
    • Be realistic in what we plan to do and in the deadlines we set ourselves!
    • Set some form of time plan - whether daily lists, weekly or monthly.
    A great boo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to help to keep things in perspective is "Don't Sweat the Small Stuff (and it's all small stuff)" by Robert Carlsson. He reminds us to keep things in perspective about time. Having said that, take your time seriously - it is your time and your life is your time!


    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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