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Advice You - Think Carefully About The Format Of Your Presentation
If you have a choice over the format of your presentation, think about which format will help you to achieve your objectives for that event. It may be that you are not g 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 iven the freedom to decide on the format, and must prepare as best as you can.
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in he subject matter while the audience passively listens. Advantages: A quick, cheap and traditional way of conveying a large volume of information to a large numb lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. er of people. Disadvantages: Tedious for the audience. Difficult for participants to ask questions or check understanding. Largely superseded by more efficient m here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe thods of information transfer such as textbooks, the internet and handouts. Not an effective method for promoting thought, changing attitudes, or teaching behavioural sk d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ills. 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 e. Advantages: Allows for an exchange of ideas between members of the group. The instructor is a facilitator. Encourages critical thinking and dialogue. Disa 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 dvantages: The members of the group must all start with a similar level of background knowledge. Labour-intensive and expensive. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically scusses a pre-defined topic with the tutorial group which is expected to have previously researched the topic and prepared questions and insights for discussion. Adv 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 antages: Allows tuition to be highly customised to the learning needs of the tutorial group. The tutor can give individual attention to each student. Disadvantag ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi s: Labour-intensive, time-consuming and expensive. ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a h practical examples and exercises. Participant involvement is expected. Advantages: Real-life situations can be explored in a controlled environment. Participan dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ts can seek solutions to their own problems from experts. Disadvantages: Labour-intensive and expensive. Tutors possessing extensive experience and knowledge are cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin required. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen xamination. Hand-on audience participation. Advantages: Allows rapid, efficient and standardised teaching of practical skills in a safe environment. Disadvan 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 ages: Labour-intensive. Suitable training materials may be expensive. Tutors must first undergo training and assessment in the skills which are to be taught. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust >Role-play
Members of the audience take turns to play different roles in pre-planned scenarios which are designed to highlight and illustrate relevant vocati y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products nal learning objectives. Advantages: Participants are able to examine and learn from their own and each other’s experiences and responses to given situations. < . 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 b>Disadvantages: Instructors may find it a challenge to devise realistic yet controllable scenarios. Participants’ behaviour in role may not reflect their real-world elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip behaviour. Conclusion: Pay particular attention to the format of your presentation, and make sure you select the right format for what you want to achieve 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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