ゼロリスク神話

日本における薬事法では、承認権者の責任が問われる。
そのため、リスクの高い医療機器は日本では承認されにくいとされる。
万が一、承認した医薬品・医療機器で重大な事故が発生した場合、承認した厚労省の課長が刑事訴追を受けることになってしまう。
つまりすべての過ちは政府が担う。欧米では、その時点の基準をもって判断したならば審査責任は問われない

日本のマスコミは、事故を起こした企業を糾弾することが社会正義と思っている。
また我々国民も、その論調に同調しがちである。
つまりゼロリスクを要求する。いわゆる「ゼロリスク神話」である。

日本では、このように苦情リスクが非常に高いため、風評悪化を懸念し、医療機器産業への参入が阻害され輸入に依存することになる。
医療機器は、年間6,000億円もの輸入超過状態である。

では、飛行機は何度も墜落事故を起こしたが、飛行を禁止したであろうか。
また、毎年交通事故で1万人もの死亡者が出るが、自動車の運転を禁止したであろうか。
もちろん、事故はできる限り起こしてはならない。
しかしながら、事故を起こしたからといって、開発を中止したり、製造を中止すると科学や技術の発展は望めない。
医療技術が進歩することを阻害してしまう。
事故を起こしてしまったら、根本的原因を追究し、二度と同じ事故を起こさないように是正を図るべきである。
医療機器業界でCAPAが重要視される所以である。

欧米では、インフォームドコンセント（十分な説明）のもと、Take your own risk.とされる。
リスクをとるかとらないかは、患者の判断による。

医薬品や医療機器における臨床試験においては、科学性、倫理性に関する基本原則を定めた「ヘルシンキ宣言」が有名である。
もう一つ、著名なものに「ベルモントレポート」がある。
ベルモントレポートは、1979年4月に米国で「研究対象者保護のための倫理原則および指針」として発行された。
臨床研究における倫理的な問題を考える際の枠組みを端的にあらわしており、その三原則は、
１．人格の尊重
２．善行
３．正義
である。
2番目の「善行」では、科学性、利益とリスクの評価を論じている。
すべての非科学的な行いは、倫理的ではない。
つまり科学を論じずに倫理面だけを論じることは全く意味をなさない。
また、我々の生命・健康は、過去の病気になった方々、被験者の方々、過去に医療事故に見舞われた方々の献身の上に成り立っている。
犠牲があったからこそ、我々が高度かつ高品質な医療を受けることができる。
我々も子々孫々のため、ある意味の犠牲を払わなければならない。

ベルモントレポートは、あくまでも米国内倫理綱領だが、研究倫理の歴史に大きなインパクトを与えた。

これまで医療機器は、医薬品を対象として制定された「薬事法」により規制されてきた。
2014年11月25日から、薬事法が一部改正される。
これにより、現在の「薬事法」という名称から、「医薬品、医療機器等の品質、有効性および安全性の確保等に関する法律」（医薬品医療機器等法）という名称に変更される。
しかしながら、承認権者の責任は従前のとおりである。

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/O067.html” title=”【VOD】【180分で要点を学ぶ】改正GMPセミナーシリーズ　品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-084.html” title=”【セミナービデオ】【180分で要点を学ぶ】改正GMPセミナーシリーズ　品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/O071.html” title=”【VOD】（全5コース）【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-088.html” title=”【セミナービデオ】（全5コース）【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

Related post

Comment

  1. I like this site very much so much fantastic info .

  2. I simply couldn’t leave your site prior to suggesting that I really loved the standard information an individual supply on your visitors? Is gonna be back continuously in order to check out new posts.

  3. Pretty! This was a really wonderful post. Thank you for your provided information.

  4. I truly enjoy examining on this internet site, it holds fantastic blog posts. “Wealth and children are the adornment of life.” by Koran.

  5. Generally I don’t learn post on blogs, but I wish to say that this write-up very pressured me to try and do it! Your writing style has been surprised me. Thank you, very great post.

  6. You made some good points there. I did a search on the subject matter and found most individuals will go along with with your site.

  7. I loved as much as you’ll receive carried out right here. The sketch is attractive, your authored subject matter stylish. nonetheless, you command get got an shakiness over that you wish be delivering the following. unwell unquestionably come more formerly again as exactly the same nearly a lot often inside case you shield this hike.

  8. I’ve recently started a site, the information you offer on this site has helped me greatly. Thanks for all of your time & work.

  9. Almost all of the things you assert is astonishingly precise and it makes me wonder the reason why I had not looked at this in this light before. This piece truly did turn the light on for me personally as far as this specific subject goes. But at this time there is one particular position I am not necessarily too cozy with and while I try to reconcile that with the central idea of the issue, let me observe just what the rest of the visitors have to point out.Well done.

  10. Nice post. I used to be checking continuously this blog and I am impressed! Very useful info specially the last section 🙂 I take care of such info a lot. I used to be looking for this particular info for a long time. Thank you and best of luck.

  11. As a Newbie, I am continuously browsing online for articles that can help me. Thank you

  12. What Is Exactly ZenCortex? ZenCortex is an optimal hearing function support

  13. I believe other website owners should take this website as an example , very clean and superb user friendly layout.

  14. Hi, I think your blog might be having browser compatibility issues. When I look at your website in Firefox, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, wonderful blog!

  15. Hi , I do believe this is an excellent blog. I stumbled upon it on Yahoo , i will come back once again. Money and freedom is the best way to change, may you be rich and help other people.

  16. There are certainly a number of particulars like that to take into consideration. That may be a great level to deliver up. I provide the ideas above as general inspiration but clearly there are questions just like the one you carry up where crucial factor might be working in honest good faith. I don?t know if best practices have emerged around issues like that, but I’m sure that your job is clearly recognized as a good game. Both girls and boys feel the impression of just a second’s pleasure, for the remainder of their lives.

  17. Ikaria Lean Belly Juice is a fast-acting weight loss supplement that is developed to incinerate stubborn fat.

  18. Thanks for the article, is there any way I can get an update sent in an email whenever you write a new post?

  19. Renew is not just another sleep aid; it’s a comprehensive nutritional formula

  20. I was very pleased to find this web-site.I wanted to thanks for your time for this wonderful read!! I definitely enjoying every little bit of it and I have you bookmarked to check out new stuff you blog post.

  21. Simply wanna comment on few general things, The website style is perfect, the content material is really great. “To establish oneself in the world, one has to do all one can to appear established.” by Francois de La Rochefoucauld.

  22. Aw, this was a really nice post. In concept I want to put in writing like this additionally – taking time and precise effort to make an excellent article… however what can I say… I procrastinate alot and on no account seem to get something done.

  23. you have an excellent blog right here! would you like to make some invite posts on my weblog?

  24. As a Newbie, I am constantly browsing online for articles that can help me. Thank you

  25. Pretty nice post. I just stumbled upon your weblog and wished to say that I’ve truly enjoyed surfing around your blog posts. After all I’ll be subscribing for your feed and I’m hoping you write again soon!

  26. Utterly written content material, Really enjoyed studying.

  27. I was looking at some of your articles on this internet site and I think this web site is rattling instructive! Continue posting.

  28. I am glad to be one of the visitors on this outstanding internet site (:, thankyou for putting up.

  29. Thank you, I have recently been searching for info approximately this subject for a long time and yours is the greatest I have discovered till now. However, what in regards to the bottom line? Are you certain concerning the source?

  30. Hi , I do believe this is an excellent blog. I stumbled upon it on Yahoo , i will come back once again. Money and freedom is the best way to change, may you be rich and help other people.

  31. Hello.This post was extremely fascinating, particularly because I was looking for thoughts on this matter last Wednesday.

  32. I’m not sure why but this site is loading very slow for me. Is anyone else having this problem or is it a issue on my end? I’ll check back later on and see if the problem still exists.

  33. Hello there, I found your website via Google while looking for a related subject, your website came up, it seems to be great. I have bookmarked it in my google bookmarks.

  34. I precisely had to say thanks yet again. I do not know the things I would’ve worked on in the absence of these creative concepts discussed by you concerning this industry. This was a real horrifying matter in my circumstances, nevertheless taking note of a new skilled form you handled it forced me to weep for fulfillment. I’m happy for the support and even wish you are aware of a powerful job you are always carrying out instructing some other people through the use of your web blog. I know that you’ve never come across all of us.

  35. What is ProvaDent? In the dynamic landscape of dental care, innovation is key to improving patient experience and outcomes

  36. Greetings! This is my first comment here so I just wanted to give a quick shout out and tell you I genuinely enjoy reading through your blog posts. Can you suggest any other blogs/websites/forums that deal with the same subjects? Thanks a lot!

  37. What i don’t realize is actually how you are not actually much more well-liked than you may be now. You’re so intelligent. You realize thus considerably relating to this subject, produced me personally consider it from a lot of varied angles. Its like women and men aren’t fascinated unless it’s one thing to do with Lady gaga! Your own stuffs outstanding. Always maintain it up!

  38. This web site is my breathing in, very superb style and design and perfect subject material.

  39. I do believe all the concepts you’ve presented for your post. They are very convincing and can certainly work. Nonetheless, the posts are too short for novices. Could you please prolong them a little from next time? Thanks for the post.

  40. Howdy would you mind sharing which blog platform you’re using? I’m planning to start my own blog soon but I’m having a hard time making a decision between BlogEngine/Wordpress/B2evolution and Drupal. The reason I ask is because your layout seems different then most blogs and I’m looking for something completely unique. P.S Sorry for getting off-topic but I had to ask!

  41. Hmm is anyone else having problems with the pictures on this blog loading? I’m trying to find out if its a problem on my end or if it’s the blog. Any feed-back would be greatly appreciated.

  42. I have recently started a site, the info you provide on this web site has helped me greatly. Thank you for all of your time & work.

  43. I’d need to examine with you here. Which is not one thing I usually do! I enjoy reading a put up that can make people think. Also, thanks for allowing me to remark!

  44. Usually I don’t read post on blogs, but I would like to say that this write-up very forced me to try and do it! Your writing style has been surprised me. Thanks, quite nice article.

  45. What Is Wealth Signal? Wealth Signal isn’t just a financial tool; it’s a new way of thinking about and achieving wealth. Unlike traditional methods that focus on external strategies, Wealth Signal emphasizes changing your internal mindset.

  46. Hi, just required you to know I he added your site to my Google bookmarks due to your layout. But seriously, I believe your internet site has 1 in the freshest theme I??ve came across. It extremely helps make reading your blog significantly easier.

  47. I think this is one of the most vital information for me. And i’m glad reading your article. But should remark on some general things, The site style is perfect, the articles is really excellent : D. Good job, cheers

  48. I believe other website proprietors should take this site as an model, very clean and fantastic user friendly pattern.

  49. I like this site very much so much fantastic information.

  50. I have been exploring for a bit for any high quality articles or blog posts in this sort of house . Exploring in Yahoo I at last stumbled upon this site. Reading this info So i’m glad to show that I have a very good uncanny feeling I discovered exactly what I needed. I most indubitably will make sure to do not overlook this website and provides it a glance on a continuing basis.

  51. I’d forever want to be update on new blog posts on this internet site, saved to my bookmarks! .

  52. hi!,I like your writing so so much! percentage we be in contact more about your article on AOL? I need a specialist on this house to resolve my problem. May be that is you! Looking forward to see you.

  53. Everyone loves what you guys tend to be up too. This sort of clever work and reporting! Keep up the superb works guys I’ve incorporated you guys to our blogroll.

  54. Hi there, I found your website by way of Google while searching for a similar matter, your website got here up, it seems to be great. I’ve bookmarked it in my google bookmarks.

  55. Hi there! Do you use Twitter? I’d like to follow you if that would be okay. I’m definitely enjoying your blog and look forward to new updates.

  56. Hi, I think your site might be having browser compatibility issues. When I look at your blog in Opera, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, amazing blog!

  57. hi!,I really like your writing very much! share we be in contact extra about your post on AOL? I need a specialist on this space to solve my problem. May be that’s you! Taking a look forward to look you.

  58. Whats Taking place i’m new to this, I stumbled upon this I have discovered It positively useful and it has helped me out loads. I’m hoping to contribute & help different customers like its helped me. Good job.

  59. Superb post however I was wondering if you could write a litte more on this subject? I’d be very grateful if you could elaborate a little bit more. Thank you!

  60. Hi there, just changed into alert to your weblog through Google, and located that it’s truly informative. I’m gonna watch out for brussels. I will appreciate in case you continue this in future. Many folks can be benefited out of your writing. Cheers!

  61. It’s really a great and useful piece of info. I am happy that you simply shared this useful info with us. Please stay us informed like this. Thank you for sharing.

  62. What i do not understood is in truth how you are no longer actually much more well-appreciated than you might be right now. You are so intelligent. You understand therefore considerably in relation to this subject, made me individually believe it from a lot of numerous angles. Its like women and men aren’t interested except it is one thing to do with Girl gaga! Your own stuffs great. At all times take care of it up!

  63. It?¦s really a cool and useful piece of information. I am happy that you simply shared this helpful info with us. Please stay us informed like this. Thank you for sharing.

  64. Spot on with this write-up, I actually assume this website needs rather more consideration. I’ll most likely be once more to learn way more, thanks for that info.

  65. hello!,I like your writing so much! share we communicate more about your article on AOL? I require an expert on this area to solve my problem. May be that’s you! Looking forward to see you.

  66. I really like your writing style, excellent info , regards for posting : D.

  67. I just like the valuable info you supply in your articles. I will bookmark your weblog and take a look at again right here frequently. I’m rather sure I’ll be told a lot of new stuff right right here! Good luck for the following!

  68. SightCare review

  69. Fitspresso review

  70. Cellu care

  71. Cellu care review

  72. Lottery defeater system reviews

  73. Sight Care is a visual wellness supplement that is currently available in the market. According to the Sight Care makers, it is efficient and effective in supporting your natural vision. The supplement is also said to have effects on different issues that affect the body like supporting the health of your brain, protecting the body from oxidative stress, and many more.

  74. Fitspresso reviews

  75. Sight care review

  76. Nano defense review

  77. Fitspresso review

  78. Fitspresso stands as a scientifically validated weight loss formula intricately crafted from potent ingredients, aimed at enhancing the body’s metabolic functions. Tailored to support the circadian rhythm and ignite the fat-burning process, this supplement is conveniently available in edible pill form for daily consumption.

  79. Lottery defeater software review

  80. Cellu care review

  81. Cellu care reviews

  82. Sumatra Slim Belly Tonic review

  83. Lottery defeater software

  84. Fitspresso

  85. Fitspresso reviews

  86. Lottery defeater reviews

  87. Lottery defeater

  88. Opini pix funciona

  89. Opinipix paga

  90. Ikaria belly juice

  91. Cellucare reviews

  92. Fitspresso reviews

  93. Fitspresso reviews

  94. Fitspresso reviews

  95. Fitspresso

  96. Dentavim is a revolutionary dietary supplement designed to promote oral health by addressing two major concerns: teeth’ cleanliness and gums’ health. Unlike typical oral hygiene products that focus solely on surface treatment, Dentavim dives deeper into the issues often caused by environmental factors, especially particulate matter, which can lead to persistent bad breath and stubborn stains. This product contains a proprietary blend of six potent nutrients derived from natural sources to enhance dental hygiene and overall well-being.

  97. Fitspresso

  98. Fitspresso

  99. Fitspresso

  100. Fitspresso

  101. Fitspresso reviews

  102. Fitspresso reviews

  103. DENTAVIM

  104. Fitspresso reviews

  105. Fitspresso review

  106. I got what you mean ,bookmarked, very nice site.

  107. Everything is very open and very clear explanation of issues. was truly information. Your website is very useful. Thanks for sharing.

  108. Zencortex reviews

  109. Lottery defeater review

  110. Neotonics review

  111. Sightcare review

  112. Sight Care

  113. Dentavim review

  114. PROVADENT REVIEW

  115. Dentavim

  116. LOTTERY DEFEATER SOFTWARE REVIEW

  117. Lottery defeater system

  118. Lottery defeater system reviews

  119. Sightcare review

  120. Unlock the potential of your pineal gland with the potent Pineal XT Dietary supplements serve as a gateway to expanding one’s range of expression, and Pineal gland support supplements, in particular, can elevate mental and spiritual capabilities. Pineal XT vitamins offer a pathway to endless joy, prosperity, health, and love. These supplements are designed to bolster the pineal gland’s function, enhance overall body performance, and boost energy levels. It stands as a premier alternative for reducing the impact of fluoride, pollutants, and the natural aging process.

  121. Neotonics gummies review

  122. Fitspresso is a brand-new natural weight loss aid designed to work on the root cause of excess and unexplained weight gain. The supplement uses an advanced blend of vitamins, minerals, and antioxidants to support healthy weight loss by targeting the fat cells’ circadian rhythm

  123. Kerassentials reviews

TOP