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This video introduces the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), and its activities ...
YouTube-Pmda Channel
To faster access to quality assured effective and safety medical products, PMDA is committed to reviewing applications for them in a prompt ...
PMDA's mission is to help improvement of public health in Japan by three-pillar system that consists of Relief Services for Adverse Health ...
(Review) Expedited Regulatory Pathways in Japan - PMDA-ATC Learning Videos.
There is a system in which some of the medical devices and IVDs can be marketed if they are certified of their conformity to the criteria by ...
Certification Criteria of Class 3
The Certification Process
Requirements for Certification by Rcbs
Illustration of how a certification body is registered
PMDA has been participating in international committees to promote the regulatory harmonization. This video introduces outline including the ...
This video introduces Center for Regulatory Science (CRS) which is established by PMDA to integrate regulatory science activities such as ...
... medical purposes without being part of a hardware medical device ... (PMDA Efforts) The PMDA-ATC Seminar - PMDA-ATC Learning Videos. Pmda ...
(Review) Drug Master File System in Japan - PMDA-ATC Learning Videos. 494 views · 8 months ago ...more. Pmda Channel. 4.33K.
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This video introduces the categories of drug application and the necessary documents for applicants to submit for regulatory approval of ...
Application Dossier
Partial Change Approval
Drug Approval Applications
Minor Change
Minor Change Notification
Good registration management (GRM) is recognized as a concept for promoting an efficient registration process for medical products.
Focusing on Grevp
Milestones during Pmda Review of New Drug and Biological License Applications
Standard Review Timeline
Pre-Submission Pre-Consultation Meeting
Review Reports
Table of Contents
Projects Conducted across Multiple Offices at Pmda
Staff Involved in Multi-Office Projects
This video introduces definition and features of regenerative medicinal products, the review process, and a specific review scheme designed ...
Definition of Regenerative Medicinal Products in Japan Regenerative Medicinal Products
Features of Rmps
Application Dossiers
Review Process
Special Conditional and Time Limited Authorization
Public Patient Registry System
Need a local team of regulatory affairs professionals who can help you register your medical device with PMDA? GRP- Japan is Located in ...
YouTube-Global Regulatory Partners Inc.
Determine the Classification of Your Medical Device
Step 4
Step 5
(Safety) Overview of Pharmacovigilance - PMDA-ATC Learning Videos.
What Is Pharmacovigilance
Why Do We Need Pharmacovigilance
Clinical Trials
Duration of Long-Term Safety Clinical Trials
Pharmacovigilance Activities
Adl Reporting System
How was pharmacovigilance developed in japan
Pharmacovigilance
Activities of Pharmacovigilance
Timeline
PMDA has started to utilize Real-World Data for assessing post-marketing drug safety. This video introduces pharmacoepidemiological analysis ...
... ). Pmda Channel•693 views · 4:33 · Go to channel · (PMDA Efforts) The PMDA-ATC Seminar - PMDA-ATC Learning Videos. Pmda Channel•271 views.
This video introduces how PMDA deals with adverse drug reaction and infection reports, and the current regulatory framework for drug ...
To promote proper use of medical products, risk information need to be shared among stakeholders. This video intoroduces risk communiation ...
Risk minimization activity is aiming to inform and update safety information effectively to health care professionals and patients as risk ...
Routine Risk Minimization Activities
Restricted Access
Alert Card
Sharing Related Information