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Practical Strategies to a successful 505(b)(2) product - Pharmaceutical Webinar By ComplianceOnline

Added by on 2010-11-18

Conference Dates:

Start Date Start Date: 2010-12-10
Last Date Last Day: 2010-12-10

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 505(b)(2) related webinar, know the complete details, key strategies, regulatory considerations, and marketing strategies for developing 505(b)(2) products.


Areas Covered in the Seminar:

The 505(B)(2) regulation and guidance from the FDA.
Strategic considerations before embarking on a 505(b)(2) development project.
Intellectual property issues with such products.
Key development steps for such products.
FDAs review process and ongoing consultation.
Challenges to developing 505(b)(2) product and possible solutions.
Examples of successful strategies for developing such products.
Searching for a 505(b)(2) project, future trends.
505(b)(2) and biosimilars.
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