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KCAS Webinar: Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
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Event Overview:
In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February 2019 draft International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines have changed or are poised to change the landscape of outsourcing bioanalysis to support drug development. Additionally, the webinar will cover gaps in bioanalytical method validation guidance to support drug development most notably flow cytometry support of gene therapies.
The webcast will highlight the areas of each guidance that indicate a change of thinking from previous documentation provided by the agency. Experts will discuss the practical side of execution of these updated parameters, where appropriate, and the impact the documents will have on the scope and time line for outsourcing of bioanalytical analysis.
Key Learning Objectives
What is new in FDA’s May 2018 Bioanalytical Method Validation Guidance?
What is new in FDA’s January of 2019 Immunogenicity Testing of Therapeutic Protein Products?
What is new in the February 2019 draft of the International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines?
What actions should bioanalytical testing labs take to adapt to these new guidelines?
Speakers: Franklin Spriggs, Director, Biopharma Services, KCAS Bioanalytical and Biomarker Services
Stephanie Bull, RQAP-GLP, Quality Assurance Team Lead, KCAS Bioanalytical and Biomarker Services
Marsha Luna, Director, Pharmaceutical Services, KCAS Bioanalytical and Biomarker Services
Time and Date: Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February 2019 draft International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines have changed or are poised to change the landscape of outsourcing bioanalysis to support drug development. Additionally, the webinar will cover gaps in bioanalytical method validation guidance to support drug development most notably flow cytometry support of gene therapies.
The webcast will highlight the areas of each guidance that indicate a change of thinking from previous documentation provided by the agency. Experts will discuss the practical side of execution of these updated parameters, where appropriate, and the impact the documents will have on the scope and time line for outsourcing of bioanalytical analysis.
Key Learning Objectives
What is new in FDA’s May 2018 Bioanalytical Method Validation Guidance?
What is new in FDA’s January of 2019 Immunogenicity Testing of Therapeutic Protein Products?
What is new in the February 2019 draft of the International Conference on Harmonisation (ICH) Bioanalytical Method Validation M10 guidelines?
What actions should bioanalytical testing labs take to adapt to these new guidelines?
Speakers: Franklin Spriggs, Director, Biopharma Services, KCAS Bioanalytical and Biomarker Services
Stephanie Bull, RQAP-GLP, Quality Assurance Team Lead, KCAS Bioanalytical and Biomarker Services
Marsha Luna, Director, Pharmaceutical Services, KCAS Bioanalytical and Biomarker Services
Time and Date: Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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KCAS Webinar: Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
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