Orthomedico Inc.
| Booth No. | 2-333 |
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| Product / Service |
Clinical Trial Service Regulatory Affairs Support Service International Support Service Market Research Study Group Organization 
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| Activities | When developing "Foods with Function Claims", it is important to bear in mind the ultimate goal, which is to register the product through notification, and plan during the initial trial stage. And in order to boost the visibility of the product, external distribution should be accompanied with academic evidence. We provide comprehensive support from the planning of trials for the notification as a "Foods with Function Claims",to the promotion of your product. |
| URL | https://www.orthomedico.jp/english.html |
Presentaion
| Date | 12 October 13:00～13:50 | Location | PH |
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| Title | Functional labeling food system and post-check guidelines-duties as a company- | ||
| Detail | Since the introduction of the Foods with Function Claims system, a wider range of health claims, as compared to FOSHU, are now being displayed. With the release of the guideline for post-notification regulation, the need for proper presentation of scientific evidence has become ever more important. Let us join Dr. Yazawa to learn about the methods of obtaining evidence for the FFC and the idea of clinical trials under this system in this lecture. | ||
| Date | 12 October 14:00～14:50 | Location | PH |
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| Title | Actual reporting practices and precautions | ||
| Detail | 7.5 year since the implementation of the Foods with Function Claims system, although the guideline has been revised several times, and the FAQ has been quite comprehensively updated, some areas are still not being covered. In this presentation, we will share with you the reality and points to be aware of when working on functional food notification from the perspective of those that deal with these on a daily basis. | ||
| Date | 12 October 15:00～15:50 | Location | PH |
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| Title | Discovery of new functional ingredients using gene expression analysis technology | ||
| Detail | In recent years, progression in researches on the relationship between gene expression and its repression mechanisms, and life phenomena have enabled identification of genes responsible for many life phenomena. It is a well-known fact that food ingredients and nutrients can affect gene expression, and many studies have reported such changes in gene expression. In this presentation, methods using technologies in gene expression analysis to discover novel functional ingredients will be explained. | ||
| Date | 13 October 13:30～14:20 | Location | PH |
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| Title | World and Japanese wellness market-How to close the gap between the world? - | ||
| Detail | Between 2013 and 2017, the wellness industry was growing by 5.8% per year, about five times faster than the global economy as a whole, which was growing by 1.2% per year. Presently, various initiatives and measures are introduced in various countries in response to this. In this presentation, we will unpack the differences between the world's and Japanese wellness industry, and the current situation of the world's wellness business. | ||
| Date | 13 October 14:30～14:50 | Location | PH |
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| Title | Multiple problems in human clinical trials | ||
| Detail | When developing foods with function claims, a strategy to differentiate one from other competitors is to include multiple outcomes in the claim-sustaining trial. However, one of the challenges that arises is the issue of multiplicity. This issue has such an impact that it can greatly influence trial results, and this has been believed to be troubling many researchers. Join us as we review them and situations where they will occur, and work out ways to tackle it. | ||
| Date | 13 October 15:00～15:20 | Location | PH |
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| Title | An example of a subjective evaluation tool used in human clinical trials | ||
| Detail | While the evaluation of subjective symptoms is considered important in the pharmaceutical industry, in the Foods with Function Claims system, results of evaluation of subjective symptoms as a primary outcome of a clinical trial can be used as evidence for sustaining health claims. However, since subjective symptoms can be evaluated easily, it is difficult to obtain a consensus among researchers. In this presentation, evaluation methods with high levels of consensus will be looked into. | ||
| Date | 13 October 15:30～16:20 | Location | PH |
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| Title | The latest situation of overseas health foods-Comparison of systems in EU China and ASEAN- | ||
| Detail | As the global wellness industry rapidly grows, countries are establishing systems for approval of health claims on food products. For those that are considering sales not only to Japan but also to the rest of the world, it is essential to understand the systems in place of the exporting countries. In this presentation, the necessary procedures when making health claims in EU, China, and ASEAN, as well as the latest trends of regualtions in those markets will be covered. | ||
| Date | 14 October 13:00～13:50 | Location | PH |
|---|---|---|---|
| Title | Discovery of new functional ingredients using gene expression analysis technology | ||
| Detail | Progression in researches on the relationship between gene expression, and repression mechanisms and life phenomena have enabled identification of genes responsible for many life phenomena. It is a well-known fact that food ingredients and nutrients can affect gene expression, and many studies have investigated such changes in gene expression. In this presentation, methods using technologies in gene expression analysis to discover novel functional ingredients will be explained. | ||
| Date | 14 October 14:00～14:20 | Location | PH |
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| Title | How to determine the number of cases in human clinical trials | ||
| Detail | One way to improve the accuracy of analysis of primary outcomes in clinical trials is to properly calculate sample size. Accurate estimation of sample size prior to trial conduction through revision of sample sizes in pilot studies and previous studies can make all the difference between positive and negative results. In this presentation, we will explain the method of sample size determination, and measures we take to improve the accuracy. | ||
| Date | 14 October 14:30～14:50 | Location | PH |
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| Title | Think about the research limits and generalization possibilities of CONSORT 2010 | ||
| Detail | Although CONSORT2010 is widely known as a guideline of format to be used when reporting randomized controlled trials, many clinical trials involving food as an intervention have been reported in formats that do not follow such guideline. In this presentation, we will discuss the research limitations that are difficult to address but are recommended by CONSORT2010, and the possibility of generalization. | ||