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Main Subject - It's the Results that Count
The way we work and the results we achieve are important. It's important to focus on outcomes but not to 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 the exclusion of other considerations. Your personal role in achieving the outcome and how you conduct ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in yourself are important. If you can adopt this mindset in the way you operate there are a number of cont lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ributions which will flow from your attitude. Listen to the views of others; let them influence you by here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe taking their views into account. Don't interrupt, no matter how keen on the result you are. Be generous d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro to and compliment your colleagues, if they gain from your achievements they will think the more of you. 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 Try to be modest; you don't have to boast and tell everyone how good you are. Be even handed by treati 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 ng everyone fairly. When I was running businesses I often used to quote that my respect was equal for ev nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ery one if they were doing a good job, (getting a result). No matter what the task if the person doing t 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 hat task is doing it well, with the right attitude, they deserve our respect. That equally applies to us ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi . Be helpful with advice. When someone asks for your advice they are complimenting you. Put your own ag ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a enda aside and try to put your self in their position so that your advice fully addresses their situatio dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod n. Show appreciation. When someone has made a contribution acknowledge it and broadcast it. Give them c cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin redit and identify them. You may well get appreciation for yourself at some time; it's a morale booster. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen Accept and adapt to criticism. Don't take it personally. Show you are big enough to take it and can ad 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 apt to change if necessary. You don't have to accept all criticism though. Be prepared to accept that y ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ou too will make mistakes. You are not infallible, no one is. Mistakes and being prepared to learn from y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products them are part of your personal development. Don't ever let self confidence become arrogance but equally . 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 draw your confidence from all areas of your life, not just at work. If you can build some of these attr elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ibutes into the way you operate you will get better results and after all 'it's the results that count'. 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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