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