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Useful Advices - Time to Speak Up! II
Our discussion here will highlight developing your presentation and meeting skills. These two areas offer you a chance to demonstrate your leadership competence, organizational and project management abilities and 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 facilitation mastery. As I said before, if these activities are not currently in your job description, you want find a way to exhibit your capabilities in these two arenas. ORGANIZE YOUR PRESENTATION 1) Prepare t ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in horoughly. 2) Introduce your topic and indicate what you will and will not be talking about. 3) Relate your topic directly to your audience and tell them why your information will be of interest to them. Refer to lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. the Audience Analysis guidelines coming up. 4) Outline a few major points and cue the audience as you go through them. For example, I will be covering three major points today and my first is... 5) Summarize you 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 main themes in your closing. 6) Ask for questions from the audience and respond graciously. If you don’t know the answer, offer to find out and contact the audience member after your presentation — and then do i d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro t! 7) Evaluate your presentation. Note areas for improvement and then think about how to get help with them. Congratulate yourself on what went well and set new goals. PRESENTATION CHECKLIST Use this checklist b 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 efore every major presentation or communication encounter where you feel anxious. It helps you to focus your energy on maximizing your chances for success. Goals: My professional goal for this presentation is... 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 My personal goal for this presentation is... Check off the following: 1) I have organized my presentation to highlight my major points. 2) I have defined all technical or ambiguous terms. 3) I have adjusted my nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically presentation to the knowledge and background of the audience. 4) My presentation notes are concise and legible. 5) I have prepared for environmental factors such as time of day, size of room, visual aids, mechani 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 cal equipment, podium, etc. 6) I have rehearsed my presentation out loud and reviewed difficult sections. 7) I have done my relaxation exercises and am physically warmed up and ready to speak. 8) I have checked ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi my personal appearance in the mirror and feel confident. 9) I have arrived at the room early and checked the lights, microphone, seating arrangement and visual aids. 10) I have a worthwhile message for my audienc ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e and I am ready to turn my attention to them. AUDIENCE ANALYSIS Some of the worst presentation horror stories happen because the speaker neglected to conduct a complete audience analysis. Sonya prepared a dynami dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod c presentation for a group of professional women on managing stress. Since she only had twenty minutes, she decided to focus on the body symptoms of stress and to use temperature-activated stress cards to illustrat cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin e her point. Five minutes into her talk, the audience got restless and told Sonya that they already had stress cards from another presentation last year. Apparently, the program planner was a new member and was una tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen are of last year’s presentation. Sonya had to abandon her prepared program and improvise an exercise on coping strategies for the group. Talk about stress! Sonya learned a painful lesson. So before you agree to do 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 a presentation, ask a myriad of questions to insure that this doesn’t happen to you. Ask your contact person for information about the following issues in this group: 1) Age 2) Professional background or work ex ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust perience 3) Sex 4) Their knowledge of the subject (prior training or other resources they have at their disposal) 5) Evidence that the audience is interested in this topic (i.e. survey results, etc.) 6) Educati y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products onal level and experience 7) Cultural make-up of the group 8) Possible practical applications with your information 9) The usual format of the meeting including length of presentation, interactive versus lecture . 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 format, special traditions of the group 10) Time for questions 11) Hunger level and if food is served 12) Space for people to write or do group exercises Typically, you may feel like you’re pulling teeth to ge elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip t the answers to these questions. Your contact person may slough you off and say, “Oh, you’ll be fine.” But be persistent so that you are in control and prepared and don’t have an unnerving experience like Sonya’s 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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