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Just Other Articles - Managing Versus Doing - Getting the Balance Right
One of the biggest challenges facing those taking on a management or supervisory role is finding the time to manage. 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 It can sometimes feel like that you have 100% of your time allocated to doing tasks and the only way to fit in the m ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in nagement part of the job is to do lots of unpaid extra hours. So how can you start to address this dilemma? Be clea lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. r on what is expected of you As a new manager you need to get absolute clarity on what is expected of you and how 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 r performance in the job will be measured. The last thing you want is to get to your appraisal and find out that you d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro have been aiming for the wrong target. Set aside time for managing If you do a 40 hour week and you know that manag 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 ement will take up about 40% of your time, block out 16 hours in your calendar each week and set up a schedule of thi 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 gs that you will work on. It might be appraisals, work planning, recruiting, staff training, customer surveys, manag nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ement meetings to name a few. Let go of the jobs you do not need to do You might love doing that piece of analysis 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 ork on excel that you have always done but you know deep down that someone else can do it. Train them and let go of ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi t. Be accessible but manage interruptions Managers love to talk about having an open door policy but make sure that ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a people understand that this does not mean they can interrupt you whenever it suits them. Have slots when your team dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod an come to you to discuss issues and make sure people know when they are. With e-mails, set aside times in you day t cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin o deal with them. If it a real emergency someone will call you. You may also need quiet time to focus on a report o tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen presentation. Divert your phone to someone else if you can or to voicemail. Build in some space in your schedule 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 hings crop up that you did not expect or anticipate, so make provision for these in your schedule so that you can be ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust flexible and responsive. Ask for help if you are getting overloaded We all have blind spots. If you are finding th y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products t you are getting overloaded and cannot seem to find a way through, ask for help. Merely sitting down with someone e . 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 lse and asking them to take a look at the challenges with you and help find solutions can get you back on track and d elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip livering great results. At the end of the day there is no magic solution but taking control is a powerful first step 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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