週次 |
日期 |
單元主題 |
第1週 |
9/06 |
Introduction to clinical trials
Clinical trial protocol design
Conduct of a clinical trial
(楊志新醫師) |
第2週 |
9/13 |
Introduction to regulatory requirements in clinical trials and birth of a new drug
(陳瑩如老師) |
第3週 |
9/20 |
Non-clinical requirements to initiate clinical trials
(林滿玉老師) |
第4週 |
9/27 |
Pharmacovigilance
(高純琇老師) |
第5週 |
10/04 |
Clinical Protocol Review- Regulator’s perspectives
(徐麗娟醫師) |
第6週 |
10/11 |
Cardiovascular diseases trials
(徐莞曾老師) |
第7週 |
10/18 |
Informed consent, institutional review board and subject protection
Audit and inspection
(沈盈君醫師) |
第8週 |
10/25 |
Statistical considerations in randomized clinical trials
(蕭金福老師) |
第9週 |
11/01 |
Early clinical trials and phase I center
(林家齊老師) |
第10週 |
11/08 |
Operation in Clinical Trials - the Role of CRA
(孫婷婷老師) |
第11週 |
11/15 |
本校校慶(停課不停班) |
第12週 |
11/22 |
Strategy and Policy for Clinical Development of International Pharmaceutical Company
(陳純誠醫師) |
第13週 |
11/29 |
Neuropsychiatric diseases trials
(張鎔麒醫師) |
第15週 |
12/13 |
臨床試驗常遇到之問題及結果判讀
(楊志新醫師) |
第16週 |
12/20 |
Final exam |
第14-1週 |
12/05(一) |
Infectious diseases trials
※上午10:20-12:10上課(303講堂)
(張上淳老師) |
第14-2週 |
12/06 |
Oncology trials
※課前須觀看預錄影片
※下午4:30-5:20上課
(許駿醫師) |