|
週次 |
日期 |
單元主題 |
|
第1週 |
9/28 |
Introduction to clinical trials
－Definition, classifications, phases, resources, organizations, regulations
（楊志新老師授課） |
|
第2週 |
10/05 |
Clinical trial protocol design
－Idea formation to development of a protocol, basic components of a protocol, design of a protocol
－Conduct of a clinical trial Initiation, registration, randomization, data collection, scheduling, safety monitoring, study material management
（林家齊老師授課） |
|
第3週 |
10/12 |
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.
（陳瑩如老師授課） |
|
第4週 |
10/19 |
Pharmacovigilance
（高純琇老師授課） |
|
第5週 |
10/26 |
Preclinical requirements to initiate clinical trials
－Animal toxicology, pharmacology, pharmacokinetics, CMC
（林滿玉老師授課） |
|
第6週 |
11/02 |
Strategy for value added clinical trial design in new drug development
－Business consideration of clinical trial in topic selection, rational of clinical trial design to fulfill "clinical proof of concept" definition in value adding, feasibility of clinical trial conduct in terms of quality, efficiency and cost, parallel business development and concept of open innovation for partnership of academia and industry, the role of TFDA/CDE and SI2C in Taiwan's new drug development.
（陳恒德醫師授課） |
|
第7週 |
11/09 |
Clinical Protocol Review- Regulator’s perspectives
（徐麗娟醫師授課） |
|
第8週 |
11/16 |
Cardiovascular diseases trials
（徐莞曾老師授課） |
|
第9週 |
11/23 |
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
（沈盈君醫師授課） |
|
第10週 |
11/30 |
Statistical considerations in randomized clinical trials
（蕭金福老師授課） |
|
第11週 |
12/07 |
Early clinical trials and phase I center
（林家齊老師授課） |
|
第12週 |
12/14 |
Operation in Clinical Trials - the Role of CRA
（孫婷婷老師授課） |
|
第13週 |
12/21 |
Oncology trials
（許駿老師授課） |
|
第14週 |
12/28 |
臨床試驗常遇到之問題及結果判讀
（楊志新老師授課） |
|
第15週 |
1/03(一) |
Infectious diseases trials
（張上淳老師授課）
（上午10:20-12:10 基醫303講堂） |
|
第16週 |
1/11 |
Final exam |
|
第17週 |
1/18 |
Strategy and Policy for Clinical Development of International Pharmaceutical Company
（陳純誠老師授課） |
|
第18週 |
1/25 |
Neuropsychiatric diseases trials
（張鎔麒醫師授課） |