HR COMPLIANCE 2011 - Understanding the new FDA Guidance for Immunogenicity Testing

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Category Immunogenicity Testing; Biologics; Biopharmaceuticals; Assays; FDA biologics compliance training; FDA guidance for immunogenicity testing; FDA assay validation guidelines

Deadline: December 14, 2011 | Date: December 14, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2011-11-17 14:09:05 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

The increase of biopharmaceuticals in the clinic during the past decade has led to an increased awareness on how immunogenicity can make or break a drug. The FDA has issued a Guidance for Industry titled "Assay Development for Immunogenicity Testing of Therapeutic Proteins" Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability.

Areas Covered in the Seminar:

This presentation reviews the following important topics to understand immunogenicity testing and interpretation when developing biopharmaceuticals:

- Immunogenicity Testing Strategy.

- Method Development.

- Method Validation.

- Sample Analysis Implementation.

- Immune Response Confirmation & Characterization.

- Specific Groups with Risks

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 12th December 2011.