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Advice You - Job-Seekers: Prepare Your Stories
You know that your great stories - call them anecdotes, examples or whatever - will hel 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 p you shine in a job interview. Stories do three things. One, they show that you really ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in grasped the question - whether it was “Have you ever had to pinch-hit under pressure?” lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. or “Tell me about a time when you had to deal with a difficult customer.” Two, they sh here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ow off your terrific communication skills. Three, they display a bit of your personalit d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro y - your wit and charm and so on. These are all good things. So you have to get some s 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 tories ready. Try to come up with at least one story in each of these categories, so th 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 ey’ll be top-of-mind when you need to produce a story in a hurry during your next inter nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically view. 1) A story about dealing with a crisis. 2) A story about handling a tough i 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 nterpersonal situation. 3) One about juggling lots of priorities (and, of course, ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi carrying the day). 4) One about having to change course to deal with changed circu ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a mstances mid-stream. 5) A story about a difficult customer (internal or external) dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod situation. 6) A story about your cost-saving or financial astuteness. 7) An a cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin necdote about learning from a mistake. 8) A story about working on a team (yawn).< tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen br>
9) One about dealing with a lot of uncertainty; and 10) One more story about 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 going above and beyond what was expected. You’ve got way more than ten stories, I know ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust . But you don’t want to pull them out of the vault at the last minute - run through the y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products m in your mind in advance so that you’re comfortable telling the story and not running . 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 off into tangents. These will be your Top Ten. If you’re job-hunting, you’ll become ver elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip y familiar with them. Then people will say about you, “Man! She’s a great story-teller. 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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