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E-Folder - Focus On the Prize
People talk to me about making personal and professional changes in their life. I hear comments about how hard they think it will be, concerns about t 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 heir ability to be successful, pressure on themselves to produce results, etc. The anticipation (what you imagine or assume will happen) of the experi ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in nce can be daunting enough to deter a person from taking the first step! How often does the anticipation match the reality of what happens? If your t lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. oughts and emotions are getting in the way of what you want, read on for 10 tips to get going and stay moving. 1. Describe (in detail) one change yo here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe want to make in your life. Consider the benefits to you, how your life will improve, who you will become, how other people and situations will benef d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro t from your success…. Be specific. 2. Identify any concerns, challenges and fears associated with this goal. Create a realistic perspective by exami 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 ing what you may be anticipating or assuming. 3. Focus on seeing yourself achieving that goal. Make the image vivid and detailed. See yourself alrea 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 dy there and step into that picture in your mind. Standing in that space, notice your feelings, thoughts, and physical sensations as you observe yours nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically lf successfully attaining your goal. From that future position, answer these questions: ? How has this change impacted your life? What’s chang 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 d? Describe in detail. ? How are you feeling, thinking, being? ? What’s the best part about being successful? ? What have you le ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi rned about yourself by achieving this goal? ? What else are you aware of? 4. Describe the picture you see on paper. Write in detail all that ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ou see, think, and sense. If you feel creative, draw a picture or make a collage to bring greater depth to your vision. 5. Looking backward from thi dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod future point, begin to recognize the steps you took to arrive at success. From here you can begin to craft a flexible strategy that will lead you to cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin the outcome you have already achieved. 6. Identify the first step and…take it! One step leads to the next. 7. Once a day (or more!), revisit the p tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen icture of success you created in steps 3 & 4. Putting your attention on the desired outcome reinforces your intention and recommits you to the goal. 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 eframe fearful thoughts with new internal messages to strengthen you and move you forward. Example: “I’m afraid to do XYZ for fear I might fail” to “ ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust I have the strength and support to move forward with confidence.” You might add, “ Each step I take is a success!” (see below) 8. Acknowledge your y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products small steps as successes. A great way to remember all of your successes is to keep a journal to document your progress. Making a change involves a ser . 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 es of action steps that produce the end result. Baby steps lead to leaps and shifts and fuel motivation by inspiring confidence and action. 9. Invit elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip people to cheer you on and support you. Experience the power of having a team behind you. Celebrate along the way!!!! Copyright 2004, Lorraine Cohe 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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