E-learning Courses : Pharmaceuticals Review

This E-learning courses are organized for regulators only.
Registration is necessary in advance.

Class: Clinical trials

1. Regulations for Clinical trials
2. First-in-Human studies
3. MRCTs and ICH E17 guideline April 25, 2025 Updated
4. Example of Bridging Strategy
5. Points of attention for consultation about MRCT from PMDA’s experience

Class: GCP

1. How to Conduct GCP inspection in Japan

 

Class: Review

1. Review Process of New Drugs
2. Application Dossier
3. Expedited regulatory pathways
4. Points to Consider in the Evaluation of New Drug
5. Review of Orphan Drugs
6. PMDA’s Experiences to Review MRCT Results
7. Review of Chemistry Manufacturing and Control (CMC)
8. Overview of Drug Master File System in Japan April 25, 2025 newly posted
9. Japanese Pharmacopoeia (JP)

 

Class: Generic Drugs

1. Review of Generic drugs
2. Bioequivalence Study

 

Class: GMP

1. GMP Regulatory system in Japan and GMP Certificate
2. PMDA's international activities as a GMP inspectorate
3. Risk assessment of manufacturing site

Class: RMP

1. Risk Management Plan (RMP)
2. Pharmacovigilance Activities April 25, 2025 Updated
3. Risk Minimization Activity
4. Pharmacovigilance activities utilizing Real-World Data in PMDA

 

Class: Labeling

1. Overview of Labeling Information (Package Insert)
2. E-Labeling system in Japan

 

Class: Risk Communication

1. Risk Communication April 25, 2025 Updated

Class: Post approval clinical study surveys

1. Basics of Epidemiology