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This webcast will be in a NEW format where you ask us the Asian regulatory and business questions and we provide the ANSWERS for 90 minutes. We will answer all different types of questions from “What is the Japan auditing process like for Quality Medical Systems compliance?” to “What would be the best business structure for us in China?” After participants have signed up, they can send questions to be answered at least 1 week before the webcast (maximum 2 questions per company please). We will answer as many questions as we can during the webcast, but cannot guarantee that all questions will be answered. In addition, questions should be focused on regulatory and business issues and not overly company-specific or product-specific issues such as biocompatibility requirements for your specific medical device in China.
Sign up now and send us your questions! We can cover various topics such as:
- Product registration
- Overviews on specific health ministries in each country, organizational structure
- Required documents
- Government fees
- Timeframes
- Using a distributor versus an independent third party
- Switching license holders
- Distributor and partner searches
- Qualifying potential distributors/partners
- Agreements and clauses to include
- Process for search
- Business strategy issues
- Choosing best business structure (rep office, branch office, etc.)
- Recruiting and setup of Asia business
- Reimbursement processes and overview
- Overall market trends in Asia
- R&D
- Clinical trials
- Sourcing
- Intellectual Property
- Enforcement
- New regulations
- Country specific regulatory issues
- Japan QMS
- Japan Foreign Manufacturer Accreditation
- China QA and GMP
- Etc.
Each dial-in number is $400.00.
This webcast will take place on June 26, 2008 and will start at 11:00 AM US Eastern Daylight Savings Time.
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