Regulatory Education for Industry (REdI): How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) – June 17, 2019
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Webinar Recordings |
Speakers | Presentations |
|---|---|---|
| The Finalized Bioanalytical Method Validation Guidance: What’s New for New Drug Applications (NDAs) and Biologics License Applications (BLAs) | Brian Booth, Ph.D. Deputy Director Division of Clinical Pharmacology V Office of Clinical Pharmacology Office of Translational Sciences (OTS) CDER | FDA |
Slides (PDF - 744KB) |
| Bioanalytical Method Validation of Abbreviated New Drug Applications (ANDAs) - What the reviewer looks for (Part 1& Part 2) |
Suman Dandamudi, Ph.D. Leah Falade, Ph.D. |
Slides (PDF - 502KB) |
| Bioanalytical Inspections: Overview and Case Studies |
Seongeun (Julia) Cho, Ph.D. John Kadavil, Ph.D. |
Slides (PDF - 340KB) |
| Accuracy and Precision in Bioanalysis: Review of Case Studies |
Charles Bonapace, Pharm.D., Director Arindam Dasgupta, Ph.D., Deputy Director |
Slides (PDF - 548KB) |
| Panel Discussion and Q&A | Brian Booth, Ph.D. Charles Bonapace, Pharm.D. Seongeun (Julia) Cho, Ph.D. Suman Dandamudi, Ph.D. Arindam Dasgupta, Ph.D. Leah Falade, Ph.D. John Kadavil, Ph.D. Sean Kassim, Ph.D. |
About
This webinar provides an opportunity for FDA/CDER offices (Office of Generic Drugs (OGD), Office of Clinical Pharmacology (OCP) and Office of Study Integrity and Surveillance (OSIS)) to discuss how they use the 2018 Bioanalytical Method Validation (BMV) guidance and what FDA expects from the regulated industry.
FDA’s 2018 BMV guidance is the official FDA document that conveys the agency’s expectations and recommendations concerning the validation of bioanalytical methods (aka bioassays) supporting drug and biologics regulatory submissions for drugs or biologics. Validation demonstrates that a bioassay can generate reliable data that are used to make or support regulatory decisions concerning safety and/or efficacy. The BMV applies to nonclinical and clinical studies for new or generic drugs, biological drugs, their active metabolites and biomarkers and veterinary applications.
Why attend?
- Understand how FDA/CDER reviewers use the bioanalytical method validation guidance to conduct drug and therapeutic biologics reviews
- Hear the changes in the 2018 BMV guidance and how those changes impact sponsors, contract research organizations, and academia
- Learn what to expect during FDA bioanalytical site inspections and how to be prepared
- Understand the aspects of FDA’s guidance on Bioanalytical Method Validation and learn reviewers’ perspective on the assessment of bioanalytical data submitted INDs, NDAs, ANDAs, and BLAs
- Increase knowledge on how to provide high quality data to support successful applications
- Understand how FDA conducts analytical inspections of BA/BE studies to verify the analytical methods are validated and analyte concentrations from clinical samples are accurate and precise
- Applicants and bioanalytical laboratories can provide high quality data to support successful application approval when they have a more complete understanding of CDER expectations
- Understand the expectations for high-quality bioanalytical data
Intended Audience
- Regulatory affairs professionals working on Investigational New Drug Applications (INDs), NDAs, ANDAs, and BLAs
- Researchers involved with testing of new drugs or new formulations of drugs, therapeutic proteins or biosimilar products
- Sponsors, contract research organizations, and academic professionals interested in bioanalytical aspects of drug and therapeutic biologic development
FDA RESOURCES
- FDA Guidance: Bioanalytical Method Validation for Industry - May 2018
- 21 CFR Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS