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Summary - Men: Friends or Foes?
For years women have been asking me some version of, “What should I do?” The situations range from “I haven’t heard from him, should I call him?” to “I’m not getting what I need, should I tell him?” The mos 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 t important thing determining the answers to these questions is where they are answered from. On a practical, everyday basis, women have two options in relating to men: Adversaries or Partners. Each approa ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ch will yield different answers to the above questions and determine your behavior overall. In an adversarial relationship, men and women are on different sides. There is always a winner and a loser. In mo lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. st places where you find dependency, you will find adversarial relationships. Between children and their parents, between employees and employers, for example, and anywhere that men and women are certain the 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 can’t live without each other. Power in an adversarial relationship is limited. One must always be concerned with who has more. It’s all about strategizing, maneuvering, and figuring out how to get what d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro you need from the other. You have to be careful, concerned, smart and concealing. Plan your moves and don’t give away your real feelings or intentions. Women have inherited an adversarial relationship to m 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 en. About two million years of dependency has sealed it into our DNA, at least for the foreseeable future. Our adversarial relationship can be seen in all the expressions of popular culture, e.g. books, fil 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 s, television programming and radio shows; lawmaking and litigation; internet jokes and verbal gender bashing. The fact that women are no longer dependent on men for food, shelter and protection doesn’t matt nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically er at the level of instinct. At the level of instinct, all men are potential attackers or protectors. We usually assume the first until proven otherwise. It’s the “all men are dangerous” instinctive concer 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 n that has women on guard most of the time, much to the dismay of good men, which would be the majority. Instinct has us behave in a variety of delightful (tongue in cheek) ways. First we use manipulation, ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi and if that doesn’t get us what we need, we resort to emasculation. It’s all about power. If we’re not sure a man will use his power for our benefit, then we must reduce his power. We emasculate men down t ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a o safe levels – where they’re handy but not threatening; the modern day equivalent of a eunuch. In a paradigm of partnership, power behaves by different rules. Power is unlimited and unfixed. It can grow, dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod and it can shrink. The more power you have, the more power I have. If we take care of each other, we’re both better off. Being honest about our needs, looking out for the other guy, being kind and generous cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin , giving and receiving support and respect – these are all natural behaviors in a partnership. Friend or Foe? Partner or Adversary? How are you going to relate to men? If you choose “Partner”, there are s tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen me things you will need to do. · First, find out what is fair to expect from your partner. Expecting him to act like a woman will cause frequent disappointment and could easily send you right back to 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 “foe”. · Second, learn how to communicate in his language. Men speak and listen differently than women. You can complain about this or adapt. Adapting will make you more effective. · Third, e ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust xamine what you really need from your partner and ask for it. Nobody can provide everything, so you have to prioritize. Ask for the most important things and anything else is a bonus. Meanwhile, here i y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products s a great guideline for figuring out what to do: Ask yourself, “What would I do if he was my friend?” This question will naturally lead you to a partner-friendly answer and clear out the manipulative strate . 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 gies you might have adopted. Let’s apply the question to, “He hasn’t called! What do I do?” A famous rule – born of manipulation – tells you to never call men. Funny, that’s not what men think! Men tell elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip us they like being called by women. It shows you care. It shows you like him too. It makes him feel like he has a partner! “What would I do if he was my friend?” would quickly lead you to making that call 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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