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

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.