Course Information
Course Semester Plan
Course Information
| No | Module Name | In Vitro Diagnostic Product Development |
| 1 | Courses code | P20B.02025 |
| 2 | Study loads | 2 credits |
| 3 | Semester | Second Semester |
| 4 | Precondition | there is no |
| 5 | Competence | This course is designed to be a knowledge-oriented course and will draw heavily upon real world trends in IVD business. This course will seek to understand basic principles of IVD business, its technology in particular, business players, trends and future possible development. The students should expect the conclusion of this course to have gained an increase level of knowledge and theoretically competency of IVD development. |
| 6 | Elements of competency | MKK |
| 7 | Type competency | main competence |
| 8 | Syllabus | 1.Introduction to IVD Bussines; 2. Key Player and System offered to market; 3. Basic Methodology of IVD; 4. Immunochemistry/Immunoassay; 5. Clinical Chemistry; 6. Hematology; 7. Microbiology. 8. Midterm examination; 9. Point of care testing; 10. Molecular Diagnostics; 11. Urinalysis; 12. Regulatory Affairs Aspect to IVD; 13. Guest Lecture (to be confirmed); 14. Hematology, Immunoassay, & POCT; 15. Microbiology dan Molecular diagnostic; 16. Final Examination |
| 9 | Attribute to soft skills | awareness, ethics, communication skill |
| 10 | Learning methods | Presentation and discussion |
| 11 | Learning media | LCD |
| 12 | Appraisal | Project Presentation 25% Project Document 25% Class Participation 15% Final Exam 35% |
| 13 | Lecturer | Prof. Muchtaridi Ph.D. Dr. Cristina Sandjaja Lucia Herminawati M.Kes |
| 14 | References | Chao-Min Cheng, Chen-Meng Kuan, Chien-Fu Chen . 2016. In-Vitro Diagnostic Devices: Introduction to Current Point-of-Care Diagnostic Devices [1 ed.]. Springer International Publishing David H Persing.2011. Molecular microbiology : diagnostic principles and practice.ASM Press Ian M. Anderson, Ian C. Reid. 2004. Fundamentals of Clinical Psychopharmacology, [2 ed.]. Taylor & Francis P. Carson, P. Carson; N. Dent.2007. Good Clinical, Laboratory and Manufacturing Practices:: Techniques for the QA Professional [1 ed.]. Royal Society of Chemistry Steven H. Woolf, Steven Jonas, Evonne Kaplan-Liss. 2007. Health Promotion and Disease Prevention in Clinical Practice [2nd Edition]. Lippincott Williams & Wilkins Various handbooks on Clinical Chemistry (Kaplan, Anderson, Tietz, etc) Recent publication of relevant subjects in various journals (Clinical Chemistry, IVD Technologies) In Vitro Diagnostic Medical Devices Directive – 98/79/EC |
Course Semester Plan