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Just Other Articles - Trainers / Presentors: Problems with the Lecture Format
ALTERNATIVES TO THE LECTURE FORMAT: How often do you use lectures as your sole training technique? Nearly alw 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 ays? Often? It’s not unusual for trainers to use the lecture technique exclusively. After all, this is what we ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in have all seen and are familiar with. The format is easily mastered, and innovation may not seem necessary whe lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. n the traditionally accepted technique garners no complaints. Unfortunately, while there are several condition here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe under which a lecture may be useful to the trainer, for several reasons it is not a very effective tool for c d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro hanging behavior in trainees. PROBLEMS WITH THE LECTURE FORMAT: The format requires that trainees receive inf 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 ormation passively, without reciprocal involvement. This tends to make trainees feel like children. In fact, t 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 his is the precise connotation that the word “lecture” calls up — an authority figure addressing children. The nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically structure of the lesson is therefore instructor-centered rather than trainee-centered. The efficacy of the lec 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 ture also suffers from its long history—lectures are expected to be boring. Very few speakers have either trai ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ning in public speech or theatre, and most lecturers, no matter how hard they try, move slowly toward either m ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a onotone or singsong patterns as they settle in. Hearing is a sense that seems to demand constant change — with dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ut it, any repetitive tone dissolves into background music. Even the addition of static visual aids helps very cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin little—the human eye is capable of seeing, recognizing, processing, and ultimately tiring of simplistic visua tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen l stimulation with surprising speed. Unless the trainer can make his material unusually interesting, somethin 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 g that few of us accomplish consistently, the constant stream of words will become monotonous to trainees. Whe ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust there is no room for active participation, it is very difficult for trainees to maintain an adequate attentio y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products n level. Finally, just as the term “lecture” suggests, there is no room for “back talk.” In a lecture format, . 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 any trainee’s expression of a different point of view on a subject matter is simply seen as disruptive or rude elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip . The more controversial (and therefore interesting) questions will be turned aside without adequate attention 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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