奈米化藥物、中藥、化妝品及食品之科技管理及法規人才養成計畫
邱繼明
財團法人醫藥工業技術發展中心
為培養衛生署及附屬機關相關業務人員能夠掌握奈米化生醫科技的最新現況，了解奈米化藥物、中藥、化妝品、食品的國際管理趨勢，並提升國內研發、科技管理及法規管理人才之專業素養，因此規劃辦理研習班及國際奈米化食品、藥物(含藥品、中藥、醫療器材及診斷器材)及化妝品健康風險與法規管理研討會。研習班及國際研討會規劃如下：
(一)辦理研習班：
課程內容規劃如下(預估每場次6小時，第6場4小時):
1.奈米生醫科技的基本觀念與應用介紹、
2.奈米生醫最新發展之檢測技術、
3.奈米生醫最新發展之分子影像學、
4.奈米生醫最新發展之轉譯奈米生物醫學、
5.奈米微粒之健康危害暴露評估與控制。
6.奈米化生醫產品健康風險與法規管理國際研討會會後討論會。
課程內容將延聘優秀專家學者，以專題講授、交流討論、實務研討等方式進行。
(二)舉辦1場為期2天之奈米化食品、藥物及化妝品健康風險與法規管理研討會 (配合奈米國家型計畫辦公室舉辦2009台灣國際奈米週活動)，此研討會規劃如下：
1.講員應至少邀請3位國外專家(以美、亞、歐等地區為主)。
2.演講內容應包括美、亞、歐等地區之奈米化藥品、中藥、化妝品及醫療器材(含體外診斷試劑)或食品相關產品之最新管理趨勢或審查原則之介紹。
(三)以上訓練課程，講員名單及演講題目在規劃前，應透過中醫藥委員會詢問衛生署意見，以符實務需求。課程應提供書面講義及講義電子檔，以供相關人員參閱。每場參訓人員至少40人次，訓練總時數至少42小時(原計畫要求為含國際研討會之時數至少40小時)。
關鍵字：奈米化、醫藥食品、科技管理、法規管理、人才培訓
Personnel Training Program About Regulation and Management of Bionanotechology Products
Chi-Ming CHIOU
Medical And Pharmaceutical Industry Technology And Development Center
To train related people in Department of Health and its subordinate departments, we are planning training classes and international seminars to introduce the health risks and regulation management of nano foods, medicines (including medicines, Chinese medicines, medical devices and diagnostic devices) and cosmetics worldwide. The purpose of the training program is to help them to catch up with updated information of Bio-nanotechnology, understand the trend of international management of nano medicines, Chinese medicines, cosmetics and foods, and enhance the professions of the development, technological management and regulation management in Taiwan. The details of the training classes and international seminars are as follows:
(1) Training courses:
The curriculum allotment is as follows: (6 hours are allotted for each class; 4 hours are allotted for the 6th class)
1. Introduction of fundamental concepts and applications of nano biomedical technology.
2. Latest testing technique developments in nano biomedical technology.
3. Molecular imaging of latest nano biomedical technology developments.
4. Nano Bio-medicine from the latest developments of nano biomedical technology.
5. Health Hazard assessment and control upon exposure to nano particles.
6.Post-international symposium workshop on health risks of nano biomedical products and management of regulations.
The curriculum covers outstanding experts and researchers hired to conduct case studies, interchanges/discussions, and practices.
(2) A 2-day symposium on ht health risks and management of regulations of nano foodstuff, medicine, and cosmetics is conducted. (In conjunction with activities of 2009 Taiwan International Nano Week undertaken by Office of National Science and Technology Program for Nanoscience and Nanotechnology. The symposium planning is as follows:
1. At least 3 experts from overseas (e.g. the U.S.A., Asia, and Europe) should be invited as lecturers.
2. The speech content should cover an introduction on the latest management trend or review standards of nano-based medicine, traditional Chinese medicine, cosmetics, and medical equipment from the U.S.A, Asia, and Europe (including in vitro diagnosis, IVD) or foodstuff related products.
3. Inquiries should be made at Committee on Chinese Medicine and Pharmacy, Executive Yuan regarding the training courses above, lecturer list, and speech topics prior to the planning to meet practical needs. Printed lecture notes and e-lecture notes should be provided at the time of course conduction for reference by concerned parties. At least 40 participants are in each class and the minimum total training hours including the symposium are 42 hours.
關鍵字：nanotechnology, medicine and foodstuff, technological management, regulation management, personnel training
