Event:
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3-hr Virtual Seminar - Japan: Regulatory Compliance
Requirements for Life Science Products
- Hosted By:
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ComplianceOnline
- Start:
- Tuesday - Feb 11, 2014 10:00 AM
- End Time:
- Tuesday - Feb 11, 2014 01:00 PM
- Location:
- Online
- This 3 hour virtual seminar on Japan regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Why Should You Attend:
If your job responsibilities require you to have knowledge of Japan’s regulatory requirements, ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements or understand how best to consider Japan into your Global Business Strategy, then you will profit from attending our training.
This 3 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor and applicant-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes were implemented, will also be discussed.
Agenda: (All time in PDT)
- 10:00 – 11:15 am (Powerpoint presentation; Session I)
- 11:15 – 11:30 am Break
- 11:30 – 12:50 pm (Powerpoint presentation; Session II)
- 12:50 - 1:00 pm (Q&A Session)
- Website:
-
Visit the website for detail info