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Cooperative Biologic Manufacturing Agreements: <br><em>Get Ready for the FDA’s First New Policy in 16 Years</em>
Registration
Audio CD/Transcript - Feb. 25, 2009 The Audio CD/Transcript will be shipped the week of March 23, 2009.
$327.00
Audio CD/Transcript - Feb. 25, 2009 The Audio CD/Transcript will be shipped the week of March 23, 2009.
$327.00
When
Event Description
Here’s just some of what you’ll learn during this in-depth 90-minute audio CD/Transcript:
- How the FDA defines the three types of cooperative biologic manufacturing and the responsibilities for each of the participating companies
- The information the BLA requires for a divided manufacturing agreement
- How to determine which manufacturer must submit a BLA for a shared agreement and what details to include
- How to ensure the quality of the product and who’s responsible
- The 17 responsibilities of a licensed manufacturer in a contract agreement
- What information the FDA requires for intermediate products
- What’s required of product labels for the three types of manufacturing agreements
- How you can use materials from unlicensed manufacturers that are in short supply