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Digg It - We Are All Consultants
In our business lives we wear many hats. We often think of our job title as the way to describe our work. In fact, in any social situation, the question, “So what do you do?” will come up early in any conversation with a new person. How do we 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 respond to this question? Invariably, we respond with our job title and the name of our organization. “I’m the Finance Manager at ABC Corp. Sometimes the conversation progresses beyond that, but often, that is all we have to say to describe ou ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in work. And that is often how we think about it as well. Finance Manager. Chef. Staff Pharmacist. Marketing Director. Salesperson. Clerk. Janitor. Principal. Supervisor. Welder. Seldom though is any job as simple as a job title might suggest lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. We play a variety of roles, and do a variety of things within the scope of that job – whatever that job is. Some people will answer that “So what do you do?” question with, “I’m a consultant.” I remember when my grandmother asked me about my here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe new job at Chevron, and I answered with “I’m a training consultant.” Grandma wasn’t satisfied with that answer, so she probed further, “but what do you do?” she asked. After a few minutes of discussion and explanation, she said, “Oh, you teach d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro dults!” That was, in part what I did then, and happily, nearly twelve years later that is still what I do. I am a trainer, speaker, leader, writer and more. But most of all, I am a consultant. It may seem logical that I am a consultant, but y 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 u might not realize that it is very likely that in at least part of your work, or in other areas of your life, you are too. Consulting is a big word – not in letters or syllables – but in scope. Consultants can play many valid roles, and theref 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 ore many roles that people play at work can be looked at as consulting. Some of the Roles Technical expert Mentor Coach Lecturer Trainer Facilitator Advisor Subject Matter expert …are all roles that consultants can hold. Any role where nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically you have (or want to have) influence, but don’t necessarily have authority, is a consulting role. If you have an expertise that your organization needs, you have an opportunity to leverage that expertise to greater value by thinking of yourself a 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 a consultant. Why it Matters Why does it make sense for many of us to think of ourselves as consultants, and not just by our job title? There are several reasons, and they all relate to your viewpoint, your contribution and your future. If y ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi u see yourself as “just a ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a help you enjoy your work life more. When people think of themselves as people trying to find ways to use their expertise to reach organizational goals, it helps them think of their role differently, again, more like that of a consultant. Consu dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod tants are constantly looking for ways to improve a situation – bringing their experience and expertise to bear on any situation. So what is the bottom line? Seeing yourself in this way allows you to grow personally and professionally. And, not cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin coincidentally, that growth will make you vastly more valuable to your organization, which is also a very good outcome! What’s Next? Once you see yourself with a broader role, or begin to think about some of the roles you play in new ways, you tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen have more means to think about your own professional development. Think about it this way - if you only think of yourself by your job title, you may be limiting your view of your own development. When you expand your view of the role you can pl 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 y – of using your expertise to impact the organization, you suddenly will see new skills that you would like to hone. Effective consultants use a wide variety of interpersonal skills expertly. Things like listening, conflict resolution, both wr ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust tten and oral communication skills, and more are critical. Beyond that there are intrapersonal skills that have high value when we play a role of a consultant. When we become clearer on our own motives, are flexible and willing to change (and u y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products nderstand change processes), and have greater self knowledge we will be more successful. On top of these things there are models and processes that we can learn to play of a variety of these consulting roles more effectively. I challenge you to . 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 think of your work and role in new ways. This rethinking may lead you to realize that MOST of the work that you do is some form of consulting, or you may find that you only play those roles someplace outside of work (in the community, as a volun elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip eer, or somewhere else), or you may find yourself somewhere in between those two extremes. If thinking about this leads you to think of your work in new ways, congratulations! You have taken another step on the road to unleashing your potential 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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