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| Image of the Japanese title of the
meeting |
The topics of the meeting
held on May 20 cover the new Pharmaceuticals and Medical Device Agency
(PMDA) - which started
operations in Japan on April 1,
2004 are discussed in details and
illustrated
View
the full program
For the first time in English a
full report of the
meeting
The 19th meeting was entirely
focused on the newly inaugurated Pharmaceuticals
and Medical Device Agency (PMDA), with the key
presenters senior officials from the agency. The
JKS report featured here contains two
parts: summary of the main presentations
and illustrations on PMDA
| Program
1. Current Trends in the
Approval Examination
2.
Clinical Trial Consultations in
PMDA
3.
Drug
Safety Measures of PMDA
4.
New
Approval Review System of
PMDA |
.List of
illustrations:
Table 1. New
categories of consultations
Table 2.
Present Consultation Categories (for new medicinal
products)
Table 3. Fees for new drug
clinical trial consultations
Flowchart
1. Procedure for consultation in PMDA
Flowchart 2. Flow-chart of the review
work by PMDA
Table 4. Department in
charge of clinical trial consultation
AVAILABLE IN THE
JKS DOCUMENT
STORE
The 26-page report is provided
for corporate customers under either single
user or
enterprise-wide
use
licenses. | 
