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Digg It - Protect Your Time from Being Robbed
What if someone asks to borrow your checkbook? And then the person asks you to sign 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 checks. Absurd, right? And yet, people freely sign over huge chunks of their l ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ives by agreeing to attend pointless meetings. Here are five things to ask about be lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ore agreeing to attend. 1) Goals What are the goals for the meeting? Why are you h here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe olding this meeting? What do you want to have when you finish? If you receive a vag d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro e answer, such as, “to discuss business” or “just to talk about something,” be warne 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 d that this meeting lacks direction. 2) Plan What is your agenda? How do you plan 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 to accomplish these goals? What will we do during the meeting? You want to know the nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically plan for the meeting before you agree to attend. A meeting without an agenda is like 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 a journey without a map. Note that a meeting without a clear goal or a complete ag ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi nda will always waste your time. 3) Me What is my role in the meeting? Why are you ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a asking me to attend? What do you expect of me during the meeting. You want to atte dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod nd only those meetings where you have an impact. Otherwise, ask for a copy of the mi cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin utes. 4) Them Who else is coming to the meeting? Why have you asked them to attend tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ? How well do they support your goals for the meeting? This tells you how to prepar 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 and what to expect. Otherwise, you could find yourself being invited to an ambush. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust 5) Logistics How should I prepare? What should I bring? What else do I need to kno y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products w about this meeting (e.g., where is it being held)? Attending a meeting without su . 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 ficient preparation will make you appear incompetent. If the time required to prepar elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip e exceeds what you can afford, suggest alternatives such as rescheduling the meeting 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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