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



VenuePalo Alto, USA - United States USA - United States

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


Topics/Call fo Papers

This webinar on the draft FDA Guidance for Immunogenicity Testing will cover recommended approach to design elements of assay development and validation parameters.

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.

Last modified: 2011-11-17 14:09:05