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E-learning Training Courses

Training Courses for specialized fields

1.  Quality Control (Herbal Medicine)    Total: 108 min
No. Title Duration
1 Review Team 2 min
2 Application Dossier 3 min
3 Review Process 3 min
4 Regulation and Review Process of OTC Drugs 20 min
5 Japanese Pharmacopoeia (JP), Japanese Standards for Non-Pharmacopoeial Crude Drugs (Non-JP Crude Drug Standards) 30 min
6 Approval Standards for Over-the-Counter Kampo Medicines and Crude Drug Preparation 30 min
7 Evaluation process and GMP inspection by prefectural authorities 20 min

 

2.  Medical Devices Review       Total: 134 min
No. Title Duration
1 Medical Device and In Vitro Diagnostic (IVD) Regulations 7 min
2 Review of Medical Devices 4 min
3 Review of In Vitro Diagnostics (IVDs) 4 min
4 QMS and Safety Measures 4 min
5 Medical Device Unit 3 min
6 Review of Medical Devices and International Harmonization 28 min
7 QMS Inspection for Medical Devices 14 min
8 International Standardization of Medical Devices 30 min
9 Clinical Evaluation of Medical Devices 14 min
10 Post-market Safety Measures for Medical Devices 26 min

3.  Phamaceuticals Review       Total: 98 min
No. Title Duration
1 Review Team 2 min
2 Application Dossier 3 min
3 Review Process 3 min
4 Achievements 3 min
5 Toxicology studies 6 min
6 Good Laboratory Practice 2 min
7 First in Human studies 5 min
8 Good Clinical Practice 3 min
9 GCP inspection procedure in Japan 6 min
10 Review of Generic drugs 6 min
11 Review of Biosimilars 9 min
12 Expedited regulatory pathways 10 min
13 Start of Clinical Trial to NDA/MAA 20 min
14 Review of New Drugs 20 min

 

4.  Multi-Regional Clinical Trial (MRCT)       Total: 85 min
No. Title Duration
1 Review Team 2 min
2 Review Process 4 min
3 History of Drug Evaluation using Foreign Clinical Data in Japan 8 min
4 Example of Bridging Strategy 3 min
5 Why MRCT? 5 min
6 Overview of ICH E17 8 min
7 GCP 20 min
8 MRCT Plan 19 min
9 MRCT Evaluation 16 min

 

5.  Pharmacovigilance      Total: 135 min
No. Title Duration
1 Safety Measures 4 min
2 Overview of PV 9 min
3 What is the RMP? 6 min
4 Pharmacovigilance Activity 8 min
5 Risk Minimization Activity 4 min
6 The Relief System 4 min
7 Pharmacovigilance System in Japan (incl. labeling process) 20 min
8 Pharmacovigilance International Cooperation 20 min
9 Communication of Safety Risk Information to Patients and Healthcare Professionals Involvement 30 min
10 Pharmacoepidemiology :  New Tool for Drug Safety Assessment in PMDA 20 min
11 E-Labeling System in Japan 10 min

 


JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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E-learning Training Courses
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