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  • Useful Advices - Embrace the Four Fundamental Truths

    You're on the way to the airport. You get on the plane with a book that you've been planning to read for quite some time. As you open your book, you glance at the person next to you. A few minutes later, you are asked a question,
    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
    and you reluctantly answer. You lower your book a bit to be polite, and after a few minutes you find yourself putting your book down and engaging in a conversation, although with a lack of enthusiasm. Then, the person next to yo
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    , let's call him John, makes an observation about you that's quite perceptive and sensitive. You start to become curious about who John is, and in the course of the conversation he tells you of an experience he has only shared wi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    h a few people. You let John know that you have had the same experience. By now, you're totally engaged and listening to every word he says. You notice every nuance in the inflection of his voice and the way he moves. Time seems
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    o stand still, and the next thing you know, the plane lands. You say good-bye to the kindred soul you have just met.

    Wouldn't you love to have these experiences more often? You feel heard, and everything seems possible. It is co
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    munication at its highest level, and it's a lost art. You can have these experiences more often if you embrace the four fundamental truths of communication.



    • The first truth is to know that what we all want on a deeper
    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
    evel is the ability to connect with one another, to touch each other's soul. Unfortunately, too many of our conversations are just an exchange of ideas and information, and we very rarely penetrate the surface. Most of our focus
    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
    is on how we are going to respond to what is being said instead of listening. When we know that what the other person really wants is connection, there is common ground on which to build. With this foundation we can build relatio
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ships that can deepen and empower those involved.

  • The second truth is to know that listening involves much more than just listening to the words. It is tuning in to the energy beyond the words. It is understanding the n
  • 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
    eds and feelings of the other person. It is about being totally engaged and at the same time being in the rhythm of life. Yes, it takes a lot of energy, but you will be energized by what you get back. Imagine living in a world wh
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    re you are truly listening and fully engaged.

  • The third truth is to know that you must take responsibility for the quality of your communication. Because we all have long-standing attitudes and beliefs, we sometimes fin
  • ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ourselves trying to convince the other person of our viewpoints. Being right then becomes the goal of the interaction rather than communication, and the next thing you know, you are in a full-fledged argument. Just think of what
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    happens when you discuss politics or religion. Is being right more important than experiencing one of those magical moments?

  • The fourth truth is that communication is a process and an art. Being a masterful communicator
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    doesn't happen overnight, but it starts with the intention to experience more connection in your busy life. Just like with other art forms, for example, dancing or music, there is a natural ebb and flow in the learning cycle. As
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    your commitment deepens to this process, you will notice that you are having more frequent glimpses of the magic that is possible in your life. The ultimate communication occurs when you are able to touch each other's soul and sh
    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
    re who you are. This newfound magic then becomes the gateway to a more fulfilling life.

    At our core level we all have the same human needs and desires. We want to know that we matter and that our life has meaning and
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    purpose. We also have the need to love and to be loved. When we accept and recognize that we all have these human needs and desires, we realize that we are part of one human family. When we work together as one, what is possible
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    n our lives, communities, and the world expands.

    Embracing the four fundamental truths of communication and applying them to your daily life is a gift to all involved. It is a way to deepen the connection in your life. As a way
    .

    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
    f reaching out to others and connecting with them, please share this article with the friends in your circle, and let them know about the advantages of being on the journey. Part of my journey has been listening and learning from
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    all the teachers who have blessed my life. Hopefully, I learn from everyone and every experience that I have. Your suggestions and comments contribute to my learning and help me to expand and evolve. Keep them flowing. Journey on


    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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