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臨床研究法第33条（研究資⾦等の提供に関する情報等の公表）及び透明性ガイドライン
浜松ホトニクス株式会社（以下、当社）は、光技術を用いた研究開発型企業であり、その取り扱う製品群には一部医療機器も含まれております。医療機器の開発・製造・販売における過程で生じうる医療機関等との連携においては、高い倫理性と公正な企業活動が重要であり、これを担保するためのより高い透明性が求められているものと認識しております。当社は、臨床研究法第33条（研究資金等の提供に関する情報等の公表）及び日本医療機器産業連合会が策定する「医療機器業界における医療機関等との透明性ガイドライン」の内容を踏まえ、研究開発等における秘密保持義務を考慮した上で、医療機関等への支払費用の情報を以下のとおり公開いたします。
- 公開方法:
当社ホームページを通じて、前期分の資金提供について決算終了後の適切な時期に公開します。 - 公開時期:
当社の決算期にあわせて、公開します。 - 公開対象:
当社が公開する医療機関等への支払費用に関する情報の対象は、次の通りとします。
A.研究費開発費等
公的規制のもとで実施される各種試験、報告、調査等(特定臨床研究費、倫理指針に基づく研究費、臨床以外の研究費、臨床試験費（治験費）、製造販売後臨床試験費、不具合・感染症症例報告費、製造販売後調査費、その他研究開発関連費用)及び企業が独自に行う調査等の費用が含まれます。
| 特定臨床研究費 | 年間の総額 施設名 部科名 件数 金額（円） |
|---|---|
| 倫理指針に基づく研究費 | 年間の総額 施設名 部科名 件数 金額（円） |
| 臨床以外の研究費 | 年間の総額 施設名 部科名 件数 金額（円） |
| 臨床試験費（治験費） | 年間の総額 施設名 部科名 件数 金額（円） |
| 製造販売後臨床試験費 | 年間の総額 施設名 部科名 件数 金額（円） |
| 不具合・感染症症例報告費 | 年間の総額 施設名 部科名 件数 金額（円） |
| 製造販売後調査費 | 年間の総額 施設名 部科名 件数 金額（円） |
| その他研究開発関連費用 | 年間の総額 |
B.学術研究助成費
医療技術の学術振興や研究助成を目的として行われる奨学寄附金、一般寄附金、および学会等の会合開催を支援するための学会寄附金、学会共催費が含まれます。
| 奨学寄附金 | ○○大学○○教室：○○件○○円 |
|---|---|
| 一般寄附費 | ○○大学(○○財団)：○○件○○円 |
| 学会寄付金 | 第○回○○学会(○○地方会・○○研究会)：○○円 |
| 学会共催費 | 第○回○○学会○○セミナー：○○円 |
C.原稿執筆料
自社医療機器の適正使用等に関する情報提供のための講演や原稿執筆、コンサルティング等業務委託に関する費用が含まれます。
| 講師謝金 | ○○大学(○○病院)○○科○○教授(部長)：○○件○○円 |
|---|---|
| 原稿執筆料・監修料 | ○○大学(○○病院)○○科○○教授(部長)：○○件○○円 |
| コンサルティング等業務委託費 | ○○大学(○○病院)○○科○○教授(部長)：○○件○○円 |
D.情報提供関連費
医療関係者に対する自社医療機器の適正使用、安全使用のために必要な講演会、模擬実技指導、説明会等の費用が含まれます。
| 講演会費 | 年間の件数・総額 |
|---|---|
| 説明費 | 年間の件数・総額 |
| 医学・医療工学関連文献等提供費 | 年間の件数・総額 |
E.その他の費用
| 接待費等 | 年間の総額 |
|---|
医療機関、医療関係者の皆様におかれましては、「臨床研究法及び医療機関等との関係の透明性に関する指針」についてご理解賜り、ご協力いただけますようお願い申し上げます。
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