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Digg It - Managing Without Arrogance
As a manager of a business, non-profit or agency you need to mak 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 e sure you do not come across as arrogant to your employees or t ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in am. This is often hard if you are dealing with folks who have no lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. thought thru their comments, questions or are so new that they here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe sk ridiculous questions. I use to have a rule that was; Ask thre d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro then me. In other words ask a co-worker or two, your next in-li 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 e manager and if you could not get an answer or they did not kno 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 the answer then as me and that makes three. This had worked for nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically me. I must say that people are always giving me advice and yet 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 dissect their comments to see if there is something I have not ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi onsidered in any of it, most often there is not and thus you mov ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e on. Yet when this happens enough perhaps it is best to turn of dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod the noise and search out your own knowledge as your time is bet cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin er spent finding the new than rehashing old thoughts, already co tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen sidered with so little else added. Think of this as the law of 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 iminishing returns if you will. So in fact the person of lots of ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust wisdom and knowledge may often appear to be arrogant, but really y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products they are being smart to maximize time. As a member of the manage . 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 ent of a company you need to be approachable but you must also m elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip nage your time without appearing arrogant. Consider this in 2006 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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