Regulations Governing Management of Infectious Biological Materials Article 35
Accredited training institutions shall comply with the following rules:1. Conduct training courses for biosafety management personnel every year.2. Assign or hire appropriate instructors, and provide suitable training venues and equipment.3. Compile teaching materials in accordance with the outline set forth by the central competent authority, and form a review panel to review the materials.4. Establish standards for fee collection and refunds, as well as service guidelines, and implement them accordingly.5. Submit the annual training results to the central competent authority for record every year.6. Carry out other matters announced by the central competent authority.The central competent authority may notify an accredited training institution to provide relevant documents and information, and may conduct supervision and inspection at the institution. The institution may not evade, interfere with, or refuse such request or action.If the application or accompanying documents and information provided by an accredited training institution contain false or misleading representations, the central competent authority shall revoke its accreditation.The central competent authority shall notify an accredited training institution to take corrective actions within a given period of time if the institution falls under any of the following circumstances:1. Failure to follow its established training plan.2. Serious deficiencies identified through accounting audit results.3. Violation of the provisions of Paragraph 2 hereof.4. Violation of other provisions of the Act, these Regulations, or other relevant rules and regulations.If the institution fails to take corrective actions within the prescribed period, the central competent authority may rescind its accreditation.
中文原文 感染性生物材料管理辦法第35條
認可訓練機構,應遵行下列規定:
一、每年辦理生物安全管理人員訓練課程。
二、編配或聘請適當師資,並提供適當之訓練場所及設備。
三、依中央主管機關訂定之大綱,編製教材,並組成審查小組審查之。
四、訂定收退費基準及服務規定,並據以執行。
五、每年將當年度訓練成果,報中央主管機關備查。
六、其他經中央主管機關公告之事項。
中央主管機關得通知認可訓練機構提供相關文件、資料,並至該機構進行督導、查核;該機構不得規避、妨礙或拒絕。
認可訓練機構填具之申請書或檢附之文件、資料虛偽不實者,中央主管機關應撤銷其認可。
認可訓練機構有下列情形之一者,中央主管機關應通知限期改善;屆期未改善者,中央主管機關得廢止其認可:
一、未依訓練計畫書執行。
二、依會計查帳結果有嚴重缺失。
三、違反第二項規定。
四、其他違反本法、本辦法或相關法令規定。
一、每年辦理生物安全管理人員訓練課程。
二、編配或聘請適當師資,並提供適當之訓練場所及設備。
三、依中央主管機關訂定之大綱,編製教材,並組成審查小組審查之。
四、訂定收退費基準及服務規定,並據以執行。
五、每年將當年度訓練成果,報中央主管機關備查。
六、其他經中央主管機關公告之事項。
中央主管機關得通知認可訓練機構提供相關文件、資料,並至該機構進行督導、查核;該機構不得規避、妨礙或拒絕。
認可訓練機構填具之申請書或檢附之文件、資料虛偽不實者,中央主管機關應撤銷其認可。
認可訓練機構有下列情形之一者,中央主管機關應通知限期改善;屆期未改善者,中央主管機關得廢止其認可:
一、未依訓練計畫書執行。
二、依會計查帳結果有嚴重缺失。
三、違反第二項規定。
四、其他違反本法、本辦法或相關法令規定。