(Note) You will be transferred to an external website (YouTube : Pmda Channel) by clicking the title below. There is also PLAYLIST that sequentially plays all the movies in this category.
Review [PLAYLIST]
- Review Teams
- Application Dossier
- Review Process
- Japanese Pharmacopoeia (JP)
- Review of Generic Drugs
- Bioequivalence Studies
- Review of Biosimilars
- First-in-Human Studies
- Expedited Regulatory Pathways in Japan
- Good Registration Management (GRM)
- Drug Master File System in Japan
- Approval review referring Drug Master File
- Review of Chemistry, Manufacturing and Control (CMC)
- Review of Over The Counter (OTC) Drugs
- Why MRCT?
- Orphan Drug Designation System in Japan
Safety [PLAYLIST]
- Safety Measures
- Overview of Pharmacovigilance
- Risk Management Plan(RMP)
- Risk Minimization Activity
- Pharmacovigilance Activities
- E-Labeling System in Japan
- Dissemination of safety risk information
- Risk Communication Tools
- Pharmacovigilance activity utilizing Real World Data in PMDA
GxP [PLAYLIST]