COURSE INFORMATION
| Module Name | Herbal Medicine Clinical Test | |||
| Module Level, if applicable | 3rd year | Types of teaching and learning | Lecture | |
| Code, if applicable | SFA-979 | Class size | 50 | |
| Semester | 5th Semester | Attendance time (hours per week per semester) | 2,5 h | |
| Person responsible for the module | Dr. Farida Hayati, MSi, Apt | Forms of active participation | Discussion | |
| Lecturer(s) | Dr. Farida Hayati, MSi, Apt | Workload | Lecture: 2 (hour) x 14 (meeting) = 28
Preparation and follow up : 3.5(hours) x 14(self-learning) = 49 Preparation and follow up: 3.5(hours) x14(group-learning) = 49 |
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| Language | English- Indonesia | Total workload | 126 Hours | |
| Relation to curriculum | Compulsory course | Credit points | 3 CU | |
REQUIREMENTS
| Requirements according to examination regulations | Minimum attendance at lectures is 75%. Final score is evaluated based on assignment and quiz (45%), mid semester exam (20%), and end semester exam (25%). |
| Recommended prerequisites | Pharmacology |
| Related course | – |
| Study and examination requirements and forms of examination | Mid-term, final term, assignment, quiz |
MODULE OBJECTIVES/INTENDED LEARNING
By the end of this course students should be able to:
- Understand the grouping of herbal medicines as well as supporting evidence and flow when requiring the implementation of clinical test
- Understand the guidelines of herbal medicine clinical test
- Understand How to designed a Good Clinical Practice test
- Study research articles on herbal medicine clinical test
- Understand the research design of herbal medicine clinical test articles
- Apply the principle of honesty and discipline in the process of Herbal Medicine Clinical Test
CONTENT
Herbal Medicine Clinical Test courses in the Pharmacy Study Program Curriculum in 2017 are given to students of 5th semester with a weight of 3 credits. This course is a compulsory course that is pursued with prerequisites pharmacology courses. This course aims to support graduate learning achievements in the form of the ability to be honest and disciplined as well as knowledge about basic knowledge and pharmaceuticals.
The main objective of this course is that students are able to understand the regulation of clinical test on herbal medicine in Indonesia, and are able to study and develop clinical research on herbal medicine.
MEDIA EMPLOYED
Text books, slides (power points), and video
READING LISTS
- Drug and Food Supervisory Agency, 2014, Regulation of the Head of the Drug and Food Supervisory Agency no 13 of 2014 concerning Guidelines for Clinical Trials of Herbal MedicineDirectorate of Traditional Medicine Supervision, 2000,
- Guidelines for the Implementation of Traditional Medicines Clinical Trials, Directorate General of Drug and Food Control, Ministry of Health of the Republic of Indonesia, Jakarta
- Guideline for Good Clinical Practice, 2017
- Drug and Food Supervisory Agency, 2005, Legislations in the field of traditional medicine, Drug & Food Supervisory Agency, Jakarta