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    "The person who constantly angers you or frustrates you...controls you." Colleen Kettenhofen

    Do you know any difficult people? Have you ever worked or lived with a difficult person? Are YOU a difficult person?! It's amazing how many participants in my leadership trainings will come up to me at the end of a program on, "Dealing with Difficult People," or "Dealing with Difficult Employees," and confide to me, "Colleen, I th
    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
    ink sometimes I'm a difficult person and just realized it today!" Well, we can all be difficult people from time to time. But what do you do with the person who is chronically difficult? A key component to life balance is learning to live and work with difficult people. Because there will always be difficult people. Here are three important points you must remember.

    1) All behavior has a positive intention - even with d
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ifficult people.

    2) Low self-esteem is often the culprit.

    3) You can't always please everybody.

    1) All behavior has a positive intention. Take for example the gossip. When someone comes into your office gossiping about everyone else, who are they trying to make look better? Themselves. That is their positive intention. As a matter of fact, while you are reading this article, what do you think the difficult people/gossip
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s are doing in your office or somewhere else? Gossiping about YOU! Just kidding. Sort of.

    I don't think gossips realize that when they gossip to you about everyone else, you are probably thinking, "I wonder what they say about ME when I'm not around?" Remember, they have a positive intention. Sick as it may sound, they are trying to make themselves look better.

    What about whiners and complainers? If someone comes to you
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    complaining and whining about how much work they have to do, or how overloaded they are, what are they looking for? They're looking for empathy and sympathy. That's their positive intention. We all have times when we're overloaded and feeling overwhelmed. But I'm talking about the real whiners and complainers. Those "emotional vampires" because they just suck the life out of you.

    What about snipers? Believe it or not,
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    even they have a positive intention. They are the difficult people who throw little "digs" your way, rattling your cage and ruffling your feathers. What's their positive intention? To make themselves look better. They think that by cutting you down, especially in front of others, that they'll look better. For example, in an open work area, a sniper might walk by and within earshot of others say to you, "Well, there goes
    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
    Shelly, on her 100th personal phone call of the day!" And, you weren't even on a personal phone call!

    Often, these snipers are the difficult people who after cutting you down and insulting you, will say, "Oh, you have no sense of humor." They're trying to put it all back on you. Really though it's about them and their own insecurities. Keep that in mind when dealing with difficult people.

    2) A root cause of why people are di
    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
    fficult is often self-esteem. A lot has been written and talked about regarding self-esteem and self-confidence. It almost seems a bit ridiculous quite frankly. For example, every child on a team winning a trophy even though they were on the LOSING team. All in the name of "self-esteem."

    And yet, a lot of difficult people do suffer from low self-esteem. Not always, but often. Only one out of every three American adults has hi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    gh self-esteem, and we're a pretty positive culture. But only one out of three adults really has high self-esteem. Some of you may be thinking, "Well, I know it's definitely not me!" That's okay. It's something you can work on. The point is, that with difficult people it's not necessarily about you. You aren't the problem. It's about THEM. They're the difficult person.

    Low self-esteem often has its roots in childhood.
    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
    For example, a child being teased in school by fellow classmates can result in one having a low opinion of themselves. You all know kids can be cruel. Sometimes it's something a teacher said or that a parent said, or being compared to Super Parent or a superstar sibling. Any number of things can cause low self-esteem. You don't always know what's going on with someone else and why they're acting the way they do.

    For exa
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    mple, years ago I taught the Evelyn Wood Reading Dynamics program. Presidents of companies, executive V.P.'s and salespeople, many of whom were seemingly confident, would quietly confide in me before class that they were nervous about taking the course. Why? Well, the more I talked with them, the more I'd find out how many of them were dyslexic way before we knew what dyslexia was. Talk about something that could wreak h
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    avoc on your self-esteem! Nowadays, we know that people with dyslexia are often VERY bright and usually have above average intelligence! Back then, however, these things were not known. So, you never know what's going on with someone else and why they're being difficult.

    Sometimes you can do all the right things and nothing works because they're a difficult person who doesn't want to change. Or, they haven't been held a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ccountable for needing to change. So remember, focus on the part you can control - you. And keep in mind these three things: 1) All behavior has a positive intention. 2) Low self-esteem might be the reason they're difficult people.

    3) You're not always going to please everybody.

    3) No, you're not always going to please everyone. Sometimes, for whatever reason, you may not like somebody, or they're not going to like you.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    You won't always please everybody so get rid of the notion that you will. People pleasers you know who you are! We can't always worry about what everyone else thinks of us. I think we realize that more and more the older we get.

    As a matter of fact, Dr. Daniel Amen has what he calls the 18-40-60 rule. The 18-40-60 rule is: When you're 18 years old, you worry about what everyone is thinking of you. When you're 40, you don
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    't care anymore what everyone thinks of you. And when you're 60, you realize nobody's been thinking about you at all! How true is that?! The older we get we realize "everybody" isn't thinking about us. They're caught up in their own stuff.

    Don't be one of those people who tends to dwell. For example, have you ever been in a situation where a week after your encounter with the difficult person you're still stewing about th
    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
    em? And thinking about them? Thinking about what you "should have said?" You know what? The person who constantly angers you and frustrates you...controls you.

    What I recommend you do, especially if you work with a difficult person, is keep a pad of paper along with a pen in your car. Anytime you're afraid you're going to say something you'd regret, especially if you're a manager or supervisor, go out to your car during
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    a break. I realize many of you are so busy you don't even know what a break is anymore! Seriously, though, write down everything you'd like to say, that you never could say. When you arrive home, tear up what you wrote or burn it. Throw it away. It's a cathartic way of getting rid of some of those emotions.

    Be careful, too, of the words you use. Avoid absolutes with the people you live and work around. For example, don
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    't say, "You always" and "You never." I guarantee it will only put that person further on the defensive. I once role played with a gentleman in one of my leadership trainings, and I said "John, you are always late. You never do the work around here." He looked at me, pointed and said, "You sound like my wife!" Everyone laughed. I think he was joking, but you get the point.

    Even big name advertisers have to be careful that
    .

    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
    their words and slogans get translated properly into other countries and languages. For example, it's been said that Pepsi's "Come alive with the Pepsi generation," translated into "Pepsi brings your ancestors back from the grave" in Chinese. Frank Perdue's chicken slogan, "It takes a strong man to make a tender chicken," was translated into Spanish as, "It takes an aroused man to make a chicken affectionate!"

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

    Companies that provide selfless information through particip
    cting leadership training around the world, especially when discussing dealing with difficult people or difficult employees, I sometimes have my participants take the following pledge. It's one that adds humor but gets the message across. Here it is:

    "On my honor, I promise, when dealing with a difficult person, that I will bite my tongue and count to 10. Because if I don't, I may say something that I will LIVE to regret!"


    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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