週次 |
日期 |
單元主題 |
第1週 |
9/10 |
授課教師:楊志新醫師�
Introduction to clinical trials
-Definition, classifications, phases, resources, organizations, regulations
Clinical trial protocol design
-Idea formation to development of a protocol, basic components of a protocol, design of a protocol |
第2週 |
9/17 |
授課教師:楊志新醫師�
Conduct of a clinical trial
-Initiation, registration, randomization, data collection, scheduling, safety monitoring, study material management |
第3週 |
9/24 |
授課教師:陳恆德醫師�
Global trend of regulatory requirements in new drug approval
-International organizations, organizations and regulations in FDA, European communities and Asia Pacific countries. Establishing Taiwan as center for drug development in Asia-Pacific area. |
第4週 |
10/01 |
授課教師:郭英調醫師�
Informed consent, institutional review board and subject protection
-Basic component of an informed consent, ethical consideration of a clinical trial
Audit and inspection
-Quality assurance, regulatory inspection |
第5週 |
10/08 |
授課教師:林志六醫師�
Pharmacovigilance and legal liability in clinical trial |
第6週 |
10/15 |
授課教師:徐麗娟醫師�
Clinical Protocol Review- Regulator’s perspectives |
第7週 |
10/22 |
授課教師:葉嘉新醫師�
Preclinical requirements to initiate clinical trials
-Animal toxicology, pharmacology, pharmacokinetics, CMC |
第8週 |
10/29 |
授課教師:邢惠婷老師�
Operation in Clinical Trials - the Role of CRA
(15:30~16:20 pm 上課) |
第9週 |
11/05 |
授課教師:陳瑩如老師�
Introduction to regulatory requirements in clinical trials and birth of a new drug
-Present regulatory requirements and all applicable laws and regulations for clinical trial, bridging study evaluation and new drug applications, and current procedures for the authorization. |
第10週 |
11/12 |
授課教師:林昇鋒老師�
Strategy and Policy for Clinical Development of International Pharmaceutical Company |
第11週 |
11/19 |
授課教師:胡賦強老師�
Statistical considerations in randomized clinical trials |
第12週 |
11/25(一) |
授課教師:李啟明醫師�
Cardiovascular diseases trials
(8:10-10:00 am 上課) |
第13週 |
12/03 |
授課教師:許駿醫師�
Oncology trials |
第14週 |
12/10 |
授課教師:林家齊醫師�
Early clinical trials and phase I center |
第15週 |
12/17 |
授課教師:張上淳醫師�
Infectious diseases trials |
第16週 |
12/23(一) |
授課教師;劉宏輝醫師�
Neuropsychiatric diseases trials
(8:10-10:00 am 上課) |
第17週 |
12/31 |
授課教師:楊志新醫師�
臨床試驗常遇到之問題及結果判讀 |
第18週 |
1/7 |
Final exam |