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32801 Conferences

How to Use Foreign Trial Data in Your NDA Approval Process

Added by Referral on 2010-07-15

Conference Dates:

Start Date Start Date: 2010-09-28
Last Date Last Day: 2010-09-28

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAs acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.

Areas Covered in the Seminar:

- Guidances and regulations that govern the FDAs acceptance of foreign trial data as pivotal data for NDA approval.
What you can do to ensure compliance.
- Design considerations and requirements for foreign trials.
- Identify which guidances and regulations govern the FDAs acceptance of foreign trial data as pivotal data for NDA approval;.
- Discuss how FDA is implementing these rules and what you can do to assure compliance; and
- Recognize design considerations and requirements for foreign trials.

For More Details: http://bit.ly/9seC8y
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