Kode Mata KuliahFD6073 / 2 SKS
Penyelenggara218 - Industrial Pharmacy / SF
KategoriLecture
Bahasa IndonesiaEnglish
Nama Mata KuliahRegulatory scienceĀ Regulatory Science
Bahan Kajian
  1. Proses registrasi sediaan farmasi
  2. Persyaratan registrasi terkait administrasi, informasi produk dan label, mutu, studi non-klinis, dan studi klinis
  3. Paten sediaan farmasi
  4. Penyusunan dokumen registrasi
  5. Pelaksanaan Izin Edar dan Perubahan pasca pemberian izin edar
  6. Perencanaan strategis registrasi obat
  1. Pharmaceutical products registration process
  2. Registration requirements related to administration, product information and label, quality, non-clinical studies, and clinical studies
  3. Pharmaceutical product patents
  4. Preparation of registration documents
  5. Implementation of drug marketing authorization and Changes after the issuance of drug marketing authorization
  6. Strategic planning of drug registration
Capaian Pembelajaran Mata Kuliah (CPMK)
  1. Mampu mendeskripsikan proses registrasi sediaan farmasi di dunia dan Indonesia
  2. Mampu mendeskripsikan paten sediaan farmasi dan keterkaitan status paten dengan registrasi obat generik
  3. Mampu mendeskripiskan persyaratan registrasi terkait administrasi, informasi produk, label, mutu, studi non-klinis, dan studi klinis di Indonesia
  4. Mampu mendeskripsikan pelaksanaan izin edar, termasuk Risk Management Plan, dan perubahan pasca pemberian izin edar
  5. Mampu memformulasikan data, terutama data studi non-klinis dan klinis, untuk menyusun dokumen registrasi
  6. Mampu menyusun strategi rencana registrasi obat untuk studi kasus yang diberikan
  1. Able to describe the registration process of pharmaceutical products in the world and Indonesia
  2. Able to describe pharmaceutical product patents and the relationship of patent status with generic drug registration
  3. Able to describe registration requirements related to administration, product information, labels, quality, non-clinical studies, and clinical studies in Indonesia
  4. Able to describe the implementation of drug marketing authorization, including Risk Management Plan, and changes after the issuance of drug marketing authorization
  5. Able to formulate data, especially non-clinical and clinical study data, to prepare registration documents
  6. Able to strategize drug registration plans for the given case studies
Metode PembelajaranKuliah, presentasi, studi kasus, tugas mandiriLecture, Presentation, Case study, Independent Assignment
Modalitas PembelajaranVisual, auditorial, sinkronous, asinkronousVisual, Auditorial, Synchronous, Asynchronous
Jenis NilaiABCDE
Metode PenilaianUTS, UAS, tugas mandiri, tugas presentasi, studi kasus, quizMid-term exam, Final exam, Independent Assignment, Presentation, Case Study, Quiz
Catatan Tambahan