New FDA Guidance on Bioanalytical Method Validation

This webinar will discuss in detail about the new FDA guidance on bioanalytical method validation, how it is similar and different from the earlier guidance issued by FDA and EMA separately. What are the new additional topics related to analysis of endogenous compounds and biomarkers, the details of method development and report writing and overall it will give a comprehensive understanding of the existing and new requirements.

Why Should You Attend:

The FDA issued the latest updated guidance on BMV in May 2018, after much anticipation following the release of the draft in 2013. It is now an authoritative document that the bioanalytical professionals need to incorporate into their standard operating procedures. The good news is that this document does not make drastic changes in the already available guidance from FDA and other global regulatory agencies, but provides a progression in the field due to advancements in science.

The guidance is equally applicable to chromatographic and ligand binding assays covering both the chemical and biological drugs. But to understand how you can apply the recommendations of this standard and avoid confusion on various standards related to same subject (ex- EMA guidance) an in-depth understanding of these topics would be helpful.

Attend this webinar to understand the core principles, parameters and specifications for bioanalysis provided in the new FDA guidance for method development, validation and sample analysis using chromatographic and ligand binding technologies. The new additional topics on the analysis of endogenous compounds and biomarkers, learn in greater details the method development and report writing. The aim of the webinar is to provide a comprehensive understanding of the existing and new requirements.

Areas Covered in the Webinar:

• Core principles, parameters and specifications for bioanalysis provided in the new FDA guidance for method development, validation and sample analysis using chromatographic and ligand binding technologies
• Comparison of the new guidance with the first FDA guidance
• What remains unchanged
• What has changed
• New ideas and topics introduced in the new guidance

Comparison of the new FDA guidance with the other major global guidance, e.g. from EMA

• Where the guidance have similarities
• Any major conflicts and how do we deal with them?

Who Will Benefit:

• Senior leadership and management teams overseeing the samples analysis for clinical and toxicology studies
• Bioanalytical professionals at all levels
• Quality assurance managers and auditors
• Regulatory Affairs managers
• CROs and consultants serving in the related fields