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This
webcast CD provides an overview of
Japan
’s most
recent medical device regulations post April
1, 2005. All
new regulatory material presented will cover issues from
April 2005 to January 2006. This Japan presentation
has 82
PowerPoint slides and the speaker is Ames Gross.
Click
here to see a sample page of our webcast
presentation.
The following topics are covered in this webcast:
- Overview
of Japan ’s healthcare system
- Application
requirements to get import/export permits for medical devices
- Classification
of medical devices
- List
of medical devices subject to government regulation
- Medical
device registration requirements
- Procurement
practices and types of tenders
- Postmarket
and surveillance requirements
- New
PMDA consultations for clinical trials
- New
adverse event reporting requirements
- New
standards for quality assurance
- Other
new regulations
This webcast
is designed for medical device professionals in regulatory affairs,
business development, international sales and marketing, or
anyone who wants to be current on a number of new
Japanese
regulatory issues.
The
presenter, Mr. Ames Gross, is president and founder of Pacific
Bridge Medical (PBM). Established in 1988, PBM is a consulting
company that has assisted over 200 medical companies with regulatory and
business development issues in Asia. Prior
to establishing PBM, Mr. Gross gained broad experience, knowledge,
and contacts in Asia while working at three major Wall Street
firms where he consummated over $500 million dollars of U.S.
- Asian transactions. Mr. Gross has a BA degree, Phi
Beta Kappa, from the University of Pennsylvania and an MBA
from Columbia University.
Click here to purchase a CD which includes
the audio and PowerPoint presentation.
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