週次 |
日期 |
單元主題 |
第1週 |
9/05 |
Introduction to clinical trials
Clinical trial protocol design
Conduct of a clinical trial
(林家齊醫師) |
第2週 |
9/12 |
Introduction to regulatory requirements in clinical trials and birth of a new drug
(陳瑩如老師) |
第3週 |
9/19 |
Non-clinical requirements to initiate clinical trials
(林滿玉老師) |
第4週 |
9/26 |
Pharmacovigilance
(高純琇老師) |
第5週 |
10/03 |
Clinical Protocol Review- Regulator’s perspectives
(徐麗娟醫師) |
第6週 |
10/10 |
國慶日 |
第7週 |
10/17 |
Informed consent, institutional review board and subject protection
Audit and inspection
(沈盈君醫師) |
第8週 |
10/24 |
Cardiovascular diseases trials
(徐莞曾老師) |
第9週 |
10/31 |
Oncology trials
※課前須觀看預錄影片
※下午4:30-5:20上課
(許駿醫師) |
第10週 |
11/07 |
Early clinical trials and phase I center
(林家齊老師) |
第11週 |
11/14 |
Operation in Clinical Trials - the Role of CRA
(孫婷婷老師) |
第12週 |
11/21 |
Strategy and Policy for Clinical Development of International Pharmaceutical Company
(陳純誠醫師) |
第13週 |
11/28 |
Neuropsychiatric diseases trials
(張鎔麒醫師) |
第14週 |
12/05 |
Statistical considerations in randomized clinical trials
(蕭金福老師) |
第16週 |
12/19 |
Final exam |
第15-1週 |
12/11(一) |
Infectious diseases trials
※上午10:20-12:10上課(基醫303講堂)
(張上淳老師) |
第15-2週 |
12/12 |
臨床試驗常遇到之問題及結果判讀
(楊志新醫師) |