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the meeting |
The critical details of the new
Pharmaceuticals and Medical Device
Organization (PMDO)
slated to
replace the
current regulatory structures of Japan on April 1,
2004 discussed in details, GCP violations and
more...
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View the full program
For
the first time in English within a week a full
report on the quintessence of the meetings is
now more accessible than ever...
Every year the regulatory and
pharmaceutical authorities in Japan are organizing
7 periodic meetings on topics such as new drug
approvals, ICH, safety and QA of the
pharmaceuticals and medical devices.
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Program
1. Current status of
pharma affairs
2. New Drug
Approvals Review
3.
Biostatistics
4. GCP
Compliance |
The 18th Information Meeting
comes in a wake of a major overhaul of the present
pharmaceutical administration, whereas the existing
three disparate bodies will form the new PMDO
organization.
The presenters - all
officials from the Evaluation and Licensing
Division of PFSB, the PMDEC and NIHS provided
concise and most update views on the future PMDO,
and also covered the increased role of the
biostatistics and most frequent violations of the
GCP.
"Since the first meeting in 1999, those
regular briefing sessions are serving as a major
channel for prompt clarification on "difficult"
issues and coming reorganizations within the
pharmaceutical administration"
- Regulatory Manager,
large biotech company
AVAILABLE IN THE JKS DOCUMENT
STORE
ANNUAL SUBSCRIPTION
Due to a
considerable interest along with the JKS documents
covering individual meetings, JKS now offer the
option to purchase an annual subscription.
Seven meetings
are
expected to be held in 2004 with the following
main topics:
- New
Drug Information Meetings - 4 (quarterly)
- ICH
topics - 1
- Safety
issues - 1
- QA and
manufacturing - 1
Inquire
for details
here.
AVAILABLE IN THE JKS DOCUMENT
STORE | 
