| Kode Mata Kuliah | FD6073 / 2 SKS |
|---|
| Penyelenggara | 218 - Industrial Pharmacy / SF |
|---|
| Kategori | Lecture |
|---|
| Bahasa Indonesia | English |
|---|
| Nama Mata Kuliah | Regulatory science | Regulatory Science |
|---|
| Bahan Kajian | - Proses registrasi sediaan farmasi
- Persyaratan registrasi terkait administrasi, informasi produk dan label, mutu, studi non-klinis, dan studi klinis
- Paten sediaan farmasi
- Penyusunan dokumen registrasi
- Pelaksanaan Izin Edar dan Perubahan pasca pemberian izin edar
- Perencanaan strategis registrasi obat
| - Pharmaceutical products registration process
- Registration requirements related to administration, product information and label, quality, non-clinical studies, and clinical studies
- Pharmaceutical product patents
- Preparation of registration documents
- Implementation of drug marketing authorization and Changes after the issuance of drug marketing authorization
- Strategic planning of drug registration
|
|---|
| Capaian Pembelajaran Mata Kuliah (CPMK) | - Mampu mendeskripsikan proses registrasi sediaan farmasi di dunia dan Indonesia
- Mampu mendeskripsikan paten sediaan farmasi dan keterkaitan status paten dengan registrasi obat generik
- Mampu mendeskripiskan persyaratan registrasi terkait administrasi, informasi produk, label, mutu, studi non-klinis, dan studi klinis di Indonesia
- Mampu mendeskripsikan pelaksanaan izin edar, termasuk Risk Management Plan, dan perubahan pasca pemberian izin edar
- Mampu memformulasikan data, terutama data studi non-klinis dan klinis, untuk menyusun dokumen registrasi
- Mampu menyusun strategi rencana registrasi obat untuk studi kasus yang diberikan
| - Able to describe the registration process of pharmaceutical products in the world and Indonesia
- Able to describe pharmaceutical product patents and the relationship of patent status with generic drug registration
- Able to describe registration requirements related to administration, product information, labels, quality, non-clinical studies, and clinical studies in Indonesia
- Able to describe the implementation of drug marketing authorization, including Risk Management Plan, and changes after the issuance of drug marketing authorization
- Able to formulate data, especially non-clinical and clinical study data, to prepare registration documents
- Able to strategize drug registration plans for the given case studies
|
|---|
| Metode Pembelajaran | Kuliah, presentasi, studi kasus, tugas mandiri | Lecture, Presentation, Case study, Independent Assignment |
|---|
| Modalitas Pembelajaran | Visual, auditorial, sinkronous, asinkronous | Visual, Auditorial, Synchronous, Asynchronous |
|---|
| Jenis Nilai | ABCDE |
|---|
| Metode Penilaian | UTS, UAS, tugas mandiri, tugas presentasi, studi kasus, quiz | Mid-term exam, Final exam, Independent Assignment, Presentation, Case Study, Quiz |
|---|
| Catatan Tambahan | | |
|---|