The PMDA-ATC offers you videos on the current topics, introduction to the main services of PMDA and what we do to promote international regulatory harmonization.
|1．||Review||2022.12.1||added ”History of Drug Evaluation using Foreign Clinical Data in Japan”, "Why MRCT?" contents|
|2．||Safety||2023.2.1||added Risk Minimization Activity content|
|3．||Relief||2020.10.31||added Relief system for ADRs content|
|4．||Medical Device New!||2023.3.1||added Third Party Certification|
|5．||GxP||2022.10.3||added New Approach for GMP/GCTP Compliance Inspection System content|
|6．||PMDA Efforts||2022.4.1||added CRS content, renewed International Activities content|
Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library.
*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The PMDA-ATC offers you videos regarding some specialized fields in the regulator-only website.
PMDA-ATC E-learning portal; https://www.pmda-atc-elearning.site/
To start the training courses, please register by the following steps;
* If you apply after February 1, the viewing period will end on March 31 due to the scheduled replacement of the system. Thank you for your kind understanding in advance.
|1．||Quality Control (Herbal Medicine)||78 min||2022.06.08|
|2．||Medical Devices Review||107 min||2022.07.26|
|3．||Pharmaceuticals Review||87 min||2022.10.18|
|4．||Multi-Regional Clinical Trial (MRCT)||114 min||2022.09.22|
Please refer to the Frequently Asked Questions (FAQ).