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  • E-Folder - Think Big: Then See the Big Picture

    Is it important to see the big picture? Companies need people who have critical thinking skills, in order to help the company move forward. However, this can’t happen if we don’t take the time to hire pe
    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
    ople with critical thinking skills so that they may see the impact of their actions and words. I have, recently been providing training programs for an agency seeking to develop their personnel's Critica
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    Thinking skills. This concept, while not new, has only been taught to various disciplines in the past two decades. The result is that many professionals have moved into positions and have missed out und
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rstanding the benefits of critical thinking, as it applies to the work setting.

    Critical Thinking very simply defined, means having an open-mind, which allows you to view the whole picture. Many people
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    elieve they have an open-mind, but their communication reveals otherwise as they quickly use words such as "no" or "that isn't the right way." Some people intend to be great critical thinkers, but their
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ctions can often be just the opposite. When we look at the whole picture, we understand the long and short impact of our actions and our decisions. We look at issues from beginning to end and understand
    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
    he long-range implications, yet we still make decisions in a timely fashion.

    We often do better applying critical thinking skills at home then we do when we are at work. In our personal lives, we may ap
    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
    ly this skill as we rent or buy a home, looking at the whole picture of what this investment offers, such as convenience and long-range value. We seek to live in a location that will keep us safe today a
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    d in the future. We purchase property with the anticipation it will at least hold its value and that it may go up in value. We see the big picture about our investments. As parents or guardians, we apply
    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
    critical thinking when we ask our children about their friends and when we teach them to pick up after themselves. I want to know the people that could influence my child and her decisions when I inquire
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    about friends. I want my child to learn that we have responsibilities and caring for our belongings is one responsibility. The beauty of critical thinking is once we apply it to our personal lives it is
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    asier to apply it to our professional life.

    Why then wouldn't we look at the big picture when hiring and training individuals? Is the person a good fit for the long-range growth of the company? Are we p
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    oviding them with training opportunities that will enhance their skills and thus will enhance the job they will perform for us? Or, are we doing minimal development and then expecting maximum output for
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s? Even buying a great home means upkeep in order for it to maintain its' value and benefits. Be sure to apply the same investment in your employees. When an employee asks to attend a seminar, avoid gett
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ng distracted by the cost of the seminar and how much the instructor will make. Instead, realize the value of the seminar if the employee applies just one skill from this training that helps retain one c
    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
    stomer or resolve one problem.

    Having recently returned from white water rafting, I found myself engaged in a conversation with someone who could not get past the cost of the trip per person. They looke
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    only at the bulk price of the trip and failed to consider the items that were required to make up the trip - the lunch, the weeks of training for our guides, the bus, rafts, safety equipment, insurance,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    etc. All of these items made up the big picture. And yes, this is a business and someone is seeking to make a profit. For me the rafting trip was a part of family bonding experience. I had to consider wh
    .

    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 we could afford, but I knew the bigger picture was the experience it gave my daughter and I to be together to nurture her self-confidence and share laughter and fun while we did this. I could not put a
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    price tag on this experience or on this memory, and what we did pay was very inexpensive for what it gave us, a memory of a lifetime.

    Have an open mind today and you will be amazed at what you can learn


    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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