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Main Subject - Complementing Your Management Team
We all have weaknesses. Whatever our roles. In management positions, one of the bigger challenges 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 is to recognise our own shortcomings and alter our own behaviours. Sometimes this can be very cha ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in llenging. Often a hint is that there are areas of your work where you feel like you really strugg lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. le, or are things you avoid. Or are things that you don't enjoy doing. So you do other things that here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe you do like and leave gaps. Spaces in your attention that are important, but get missed. You are d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro not alone, your gaps are natural, because no-one is perfect, not even those at the very top of 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 ir game. You see, the very best executives realise that they aren't completely rounded. The ones 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 who have wonderful strategic visions may not be the best with the purse strings. The ones who have nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically a very focused view of the operational standards of their business, may well not see the possibil 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 ities. The business world is littered with big-time bosses that missed a trick or two. You may ha ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi e worked with one or two! The best ones realise this and take action. Even though it might mean g ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a etting over that truly biggest hurdle for top bosses, their ego, the best are able to get the poin dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod t that they aren't perfect and they need help, for the greater good. So they surround themselves cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin with others who have the skills they lack. A great visionary may have an expert with tight financi tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ng. The detail guy may have someone who is a whiz at thinking off the wall and with wow ideas. It 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 s a blend that the very best bosses understand and let go of. They give up control in the areas wh ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ere they are not as strong. If you have weaknesses, accept it - it's natural and where those are, y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products look for people in your team who have those skills. Nurture them and let them have a free rein 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 manage that part of your business where you can't - not effectively anyway. And get on doing you elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip r stuff really, really well, without the worry about those bits that you are less comfortable with 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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