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  • Useful Advices - Leadership Skills For A Crisis

    TIME. TIME. TIME is the main problem. Or rather, lack of time. Too little time to plan, to decide, to execute the plan.

    Your usual coping strategies, even your best ones, may not work in a crisis. New strategies for gathering information, judging its usefulness, and deciding on the best option are absolutely necessary.

    You've probably never faced a situation like this. That's why it's a "
    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
    CRISIS". Otherwise, it would be a problem or a challenge, but not a crisis. For a problem or a challenge, you have a set of learned behaviors, such as: 1. gather the facts, 2. consider options, 3. choose the best, then 4. act. There is no need to be fast thinking, no time restriction.

    In a crisis, you need perceptual skills of a different order. You must be quick to look, listen, fe
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    el, and smell to gather the pertinent information for survival. In our culture, we've seldom had to do this. Maybe never before. Some practice helps.

    Once you've gathered the danger information, the exit information, the key pieces of the environmental data, you must quickly choose the best option, one you've never tried before, and then do it.

    Our habits, our usual mental patterns, pro
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    bably won't work here. You can't take the elevator, and which stairs, up or down? Maybe the only exits are windows. Do they open? If not, how do you break the glass? What floor are you on? How high up are you? A million questions to answer with your perceptions and only a few moments to find the best answers. How do you prepare for a crisis?

    Here are some suggestions to lay down some syna
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    pses in your memory so if the real thing happens, you will have rehearsed for faster, better decisions.

    Decision Making in a Life and Death Situation

    The first mistake you may make is the result of the way the brain processes your perceptions. The brain's first response is, of course, fight or flight or freeze. For all of these responses the brain first activates patterns you've already u
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sed. This may evoke the worst possible response. Instead of falling into a habitual pattern, you probably need to become creative. Non-survivors of Hurricane Katrina barricaded their doors and drowned when the first wave hit. The survivors used their doors as rafts to float out. Creative thinking.

    If you only see one option to the crisis, take a moment to find two more, then select the
    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
    best. And be creative while thinking up options. Creative thinking, here, simply means to find new uses or solutions for available objects or situations

    Doesn't searching for three options take time? Yes, but not much. The brain works fast. This simple pause could save your life. Here’s an example of a life-threatening situation in which the best answer is counter-intuitive. If you are cau
    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
    ght in a whirlpool, don't fight it. Instead, relax, drift to the bottom of the whirlpool where the centrifugal force is less, then you can swim out of the whirlpool and up to the surface. How do you relax when you seem to be drowning? Ah yes, there's the rub. We'll give you some strategies for this later. When you are panicked, your brain shuts down. Most of your blood goes to your limbs an
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    d you will not be creative. A peak performance state with its attendant relaxation could be your magic thinking answer. We present this in Chapter 7.

    Be sure you've used your eyes, ears, hands (if you are in the dark), and nose to gather as much sensory information as possible, then you’ll be able to quickly summon three options. Only then, should you act. These instructions need some fine
    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
    -tuning, but that's the general idea of how to use your brain to make the best first move. One more point to keep in mind, as you gather your perceptions, here and now, consider options, and begin to act is; be prepared to change course as any new better options appear. Sheets? If no ladder. Curtains? If no sheets? A window ledge, if neither. A wet towel? Is there time? Hands and knees? Jum
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ping from one roof to another? These are drastic measures, and it's conceivable that finding unorthodox moves could save your life. And your child's life.

    I remember being in a small hotel in Los Angeles at 2 am when the fire alarm began clanging. I had been dreaming of the seminar I was teaching in Los Angeles and I thought at first it was a school bell. It woke me up. Disoriented, I reac
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hed for the telephone and a calm operator told me to find the stairs and exit immediately. First, I looked out the window. No fire truck. I was on the fifth floor. I found my robe and slippers and took time to put these on. This time could have cost me my life. My nightgown was very short and at that moment, there was no smoke, a calm operator, and so my modesty overrode my survival instinc
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t. Stupid.

    Most of the hotel guests were milling around on the sidewalk and street by the time I joined them. I was so glad I had found my robe. Some of them were dressed in street clothes. Some wore lipstick. Were they courageous or already dressed at this hour? We stood around for almost half an hour while the kitchen fire was doused, then returned to our beds. Once back in bed, I realiz
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ed my response (I also grabbed my purse) was not the brightest. I made a resolution to change my behavior if a fire alarm woke me up again in this life. I'll be the one in the short nightgown. Are You A Crisis Expert?

    If you have a job that entails dealing with crises, then you have been taught a certain set of procedures. Since each crisis by its very nature, is somewhat different, you h
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ave already discovered that these "set pieces" do not always fit. You must adapt to what is happening. These mental "adjustments" is what this book is about. We are not recommending specific save-your-life techniques. There are several well-researched books on this. See Index. What we are focusing on here, are the optimum thinking skills to allow you to choose the best next move when you ar
    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
    e pressed for time. The thinking skills that work best for each unique situation. You have to be inside the unique situation with all your perceptions open and working to figure out the next best step. Since the next step could be your last, there is a certain urgency to this figuring out.

    Is This Your First Crisis?

    For those people not accustomed to crises, the urgency itself may be th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eir undoing. Thus this rehearsal guide.

    You may find some of the mental shenanigans we recommend useful in other areas of your life as well. In teaching corporate America for the last 25 years, I've found that business people often use the same strategy to buy a house, choose a wife, select a pair of blue jeans, and turn down a merger. Almost everyone I've taught could learn more about the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ir decision-making processes to improve their decisions and their lives. Each of us makes a decision with each breath yet we seldom think about how we do this.

    The role of perception in potentially saving your life will be considered first because that's where your thinking strategies begin. Whether you know this or not, it's true. Then, you will probably find other areas of your life impr
    .

    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
    oved by these skills. Refining the quantity and quality of all your perceptions could not only save you from harm but also improve your day to day decisions. All of us delete and distort our perceptions.

    Here are the ABC’s of improving your ability to perceive the world around you so that you see, hear, feel, and smell data will help you in a crisis. Each of our actions begins with our per
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ceptions. Better decisions and actions depend on better perceptions.

    These perceptual awareness ideas are arranged in short bursts so that you can review them quickly. The mnemonic is designed to help you remember the ones you need. You might memorize the ones that are new for you, just in case you need them. The ABC mnemonic is s proven strategy to help you with the process of remembering


    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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