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E-Folder - Leadership Quality Through Kindness
In days past, loyalty was a given. The worker in past generations frequently remained with a company for h 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 or her lifetime. It was not just a matter of a company town, it was an ethic ... the job was guaranteed ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in by tacit tradition and in return for an honest day’s work, the employee had the comfort of lifetime employ lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ment. Frequently it was an unwritten contract. Loyalty was universal and protection of the employee was f here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe undamental and gratuitous. Employees spoke well of their companies and insured that quality service was gi d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ven and excellence in product was achieved. With the advent of a more troubled world, the intense focus 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 of the corporate conglomerates on profits, the speed of communication, other technologies and a more permis 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 ive society we have drifted to a time of a created urgency. The perception of human value has diminished a nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically nd with it, loyalty. So it is the rare enterprise that has leadership which, once again by example , dem 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 onstrates loyalty. Even in the compassion for profit must lie some allegiance to the folk who produced i ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi t. Employees still respond to kindness and loyalty. I recently persuaded a business owner to pay a medic ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a al bill for a key employee, in an organization that does not provide a health benefit. The employee had b dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod een missing work due to an undiagnosed and debilitating ailment. I arranged with her to see a doctor. Then cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin I “suggested” to the employer that he offer to pay the bill, which he did. When I related that to the emplo tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ee, she was overjoyed. Obviously, one of the roadblocks for her was the cost of treatment. She could not 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 wait to thank the employer and she is now “glued” to her job, with a loyalty reminiscent of days past. An ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust isolated case, but an excellent example. Weak leaders (and therefore ineffective) do, in fact, protect t y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products heir own insecure positions by hoarding their control. It is a classic defense mechanism for dysfunctional . 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 leaders. It is a particularly difficult situation when the subordinate is strong and competent. That is o elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ne of those cases when corporate “politics” can fester into a nasty situation. Unfortunately, it happens 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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