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. Why MRCT?
4. Overview of ICH E17
5. Example of Bridging Strategy
6. 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 Chemistry Manufacturing and Control (CMC)
6. PMDA’s Experiences to Review MRCT Results
7. Review of Orphan Drugs
8. Japanese Pharmacopoeia (JP)

 

Class: Generic Drugs

1. Review of Generic drugs
2. Bioequivalence Study

 

Class: Overview of Post Marketing Safety

1. Safety Measures
2. Overview of Pharmacovigilance
3. Review of Safety Information in Japan

 

Class: RMP

1. Risk Management Plan (RMP)
2. Pharmacovigilance Activity
3. Pharmacovigilance activities utilizing Real-World Data in PMDA
4. Risk Minimization Activity

 

Class: Labeling

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

 

Class: Risk Communication

1. Risk Communication Tools
2. Dissemination of Safety Risk Information

 

Class: Post approval clinical study surveys

1. Basics of Epidemiology