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Useful Advices - Strategies for Implementation-How to Follow Through on Your New Year's Resolutions
For most of us, the start of a new year is a time of reflection. A review of the year gone by and an opp 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 ortunity to set goals for the year ahead. Intentions are good and motivation is high. The challenge lie ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in s in the predictable loss of steam that ensues as we move past the holiday season and back into our work lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. aday lives. Make no mistake. Setting goals is easy. Following through is the hard part. To assist you i here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe n seeing those New Year’s goals and resolutions come to life, Bywater Consulting Group presents you with d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro : Liz Bywater’s Strategies for Implementation: How to Follow Through on Your New Year’s Resolutions 1) 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 Review your goals. Keep the important ones. Discard the ones that don’t make sense. 2) Prioritize. Dec 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 ide what requires immediate action, what belongs in the mid-term, and what can be deferred to a much lat nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically er date. 3) Organize. Figure how to best approach the daily, weekly, monthly, and annual tasks entailed 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 in meeting your goals and resolutions for the year. Put a system in place for efficiently attending to ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ach of these tasks. 4) Enlist help. Don’t try to tackle it all yourself. Delegate where feasible. Outso ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a urce where appropriate. 5) Share the news. Tell someone about your goals and your strategies for reachi dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ng them. 6) Create accountability. Set up a system for reporting your progress to someone who’s investe cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin d in your growth. This can be a business partner, a boss, a peer, or a spouse. 7) Celebrate your succes tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ses. When you’ve made progress toward a goal, recognize it. Take pride. Use it as incentive to keep movi 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 ng forward. 8) Get feedback. Ask others how they see you and your progress. Use their input to build up ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust on your strengths and neutralize your weaknesses. 9) Don’t obsess. Plan, prepare, and then execute. Don y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ’t get caught up in over-analyzing or striving for perfection. 10) Give yourself a break. Remember to t . 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 ake time to relax and refresh yourself. Don’t run yourself so ragged that you lose focus, stamina, and c elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip reativity. They’re vital if you are to reach your goals and see your New Year’s resolutions come to life 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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