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Digg It - Towards Intercultural Understanding
An individual’s ability to forge effective relationships across cultures is influenced by a very personal and highly complex mixture of emotional and cognitive processes. Anyone contemplating an overseas posting feels apprehensive about stepping into the unknown. The mere knowledge that we are leaving our own cultural comfort zone can trigger all sorts of subconscious defensive tactics that can make it difficult to op 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 erate effectively the new environment. The widely known work of Milton Bennett helps to elucidate the process of adaptation to a new culture. In his work, Developmental Model of Intercultural Sensitivity, 1993, he describes six main stages in the development of intercultural sensitivity: 1. denial 2. defensiveness 3. minimization 4. acceptance 5. adaptation 6. integration I want to revisit ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in these six stages and discuss them as they relate to the potential problems of people working in intercultural environments. The denial stage refers to an individual’s inability to even notice cultural differences. I witnessed this once when a middle-aged Saudi man studying in the UK complained to me that his English teacher was treating him like a ‘donkey’. I was very puzzled by this because I knew the teacher conce lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ned was very polite with the students and showed great respect to those who were older. After some ferreting around I discovered that the teacher was in the habit of saying ‘sh’ when the students were talking too much. Apparently such a noise is used for donkeys in Saudi Arabia. Why, I wondered, had the Saudi man not noticed that the streets of London were free entirely of donkeys? Looking at the incident now, I can here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe see that he was clinging to his own cultural norms like a life raft in the uncertain seas he was currently experiencing: a world where young women were allowed to teach older men, where his host family did not have a separate part of the house for the women and children, where he couldn’t eat freely because even pastry for a dessert might contain pork fat . He was totally disoriented and could not tell if he was bein d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro insulted or not. He had gone into a kind of cultural default mode. I fell into the denial trap myself too. In my first experience of working in France, I blithely scheduled the period immediately after noon to make local telephone calls, just as I used to do in London, where lunch was often just a quick sandwich break at around 1pm. In a Homer Simpson-like moment of recognition, it dawned on me that this was the sa 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 red French lunch break and, of course, nobody was ever in their office. I had tried to salvage a little of my old, familiar routine in order to feel more comfortable with the working day and was in denial about this great French tradition. I really didn’t want to see that the French could abandon between two or three hours in the middle of the day to non-work activity. The point here is that it’s not sufficient to k 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 now about differences on an abstract level, we need to experience them to recognize them, and this transitional period takes time. But it also requires a willingness ‘to see’. If we feel more secure by keeping on the blinkers we will never be able to accept or be accepted in the new environment. The defensive stage occurs after such recognition and is a reflection of just how disturbing it is when we see how alien th nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically host culture is. We need to cling to a concept of what is normal and so we perceive the new culture as skewed. Our own way of doing things is automatically better and right. And it is often counter intuitive. I confess again. I was in the habit of treating my French secretary as an equal. I would ask her so politely to do things ‘if she had time’, if she wouldn’t mind’. She did nothing. In France, you give a subordin 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 te an order otherwise it is not interpreted as requiring action. I resisted this for ages. How abrupt, how rude, I thought. How much more civilized to be egalitarian and indirect like the British. Clearly this position is going to cause difficulty if it results in confrontations between us and our co-workers. As the outsider, we will be seen as arrogant at best, perhaps stupid and na?ve at worst, and people will sens ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi that we do not respect or trust their way of doing things. Yet even so, this stage is a step forward. We do at least know that the differences exist and we now need to build bridges so that we look for what works best in the given situation. The stage of minimization can be seen as a means of overcoming our defensiveness. In order to cope with the differences, we try to minimize their significance and concentrate in ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a stead on the common values and needs that humanity shares. While this stage is likely to see us developing tolerance of diversity, it may also mean that we fail to recognize the importance of cultural difference. Cultural identity is deeply embedded in our psyches and, however much we have similar fundamental needs, we also have crucial differences that make each of us unique. In the shifting balance of cultural aware dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ess, we may need at this stage to think more deeply about our own cultural norms so as to be able to compare them with the culture we are in and reaffirm the significance of each. A very simple example of this was how I had to overcome my attempts to make my French neighbours and friends participate in stand-up, buffet-style lunches. Oh yes, in France many of the differences concern attitudes to food. It wasn’t suf cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin icient just to put on a good spread and supply some fine wine in the hope that people would walk around with a plate and glass in their hands—the French take food seriously and they want everyone to be seated and to pay proper respect to a meal. Difficult, yes, if you’re a bit short of chairs and you really want people to mingle, but in the end, you can’t beat them. When we can truly accept cultural difference we no tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen longer judge different behaviour patterns as better or worse than our own, but realize that differences are an inherent feature of our complex world. We understand that other people have good reasons for their behaviour, even if we don’t like the way they do things. At this stage we are also ready to see that our own behaviour will seem strange to some groups too. Acceptance is the phase when we also begin to see the 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 dvantages of difference. We can broaden our perspectives, deepen our understanding so as to move to the stage of adaptation. By adapting to the new culture we can start to see things from a different point of view. No longer do we stand outside and look in. We now realize that there are many ways of operating, and that no single solution exists to a problem. We have reached a stage when we can build useful bridges be ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ween groups to help resolve conflicts and difficulties. We can start thinking more creatively and genuinely forge new behaviours that both parties across a cultural divide can accept. At all stages of developing intercultural understanding we can meet obstacles. At the point of adaptation we can fall into a sense of real cultural confusion. If we operate equally well in more than one culture, we may have sense of cul y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products tural confusion and identity crisis. This is seen often in second generation immigrants who have been brought up in two cultures but don’t feel fully integrated into either. If we can successfully take the process of adaptation even further, we can integrate fully into another culture, still moving easily between cultures without losing our own sense of identity. Yet even cultural integration, a stage that is probabl . 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 not necessary for most people who work internationally rather than settle permanently, is not without its difficulties—others may be suspicious of us, fearing that we don’t really have an allegiance to any one culture. A British politician once famously raised the question of British immigrants: yes, they are British but which cricket team so they support? Embarking on an overseas posting is both exciting and daunti elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip g but companies need to be aware of these learning stages and their complexity. They need to give people sufficient time to work through each phase and, of course, equip them with adequate knowledge to raise their awareness of the pitfalls before they leave. The stakes are high. Failure to handle the intercultural issues properly can lead to major breakdowns in communication with resulting deterioration in performance 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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