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  5. Regulatory Education for Industry (REdI): How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) – June 17, 2019
  1. Development & Approval Process (Drugs)

Regulatory Education for Industry (REdI): How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) – June 17, 2019

Regulatory Education for Industry (REdI): How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) – June 17, 2019

CDER SBIA Webinar Series

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.

Date Recorded
June 17, 2019
10:00 a.m. – 2 p.m. Eastern
Monday

Recordings and Presentations     Agenda

This on-demand webinar is FREE.

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 Speakers

Brian Booth, Ph.D.  
Deputy Director
Division of Clinical Pharmacology V
Office of Clinical Pharmacology
Office of Translational Sciences (OTS)
CDER | FDA

Suman Dandamudi, Ph.D.  
Staff Fellow

Leah Falade, Ph.D.
Lead Pharmacologist
Office of Bioequivalence | Office of Generic Drugs
CDER | FDA

Seongeun (Julia) Cho, Ph.D.
Division Director

John Kadavil, Ph.D. 
Deputy Director
Division of Generic Drug Bioequivalence and Evaluation
Office Study Integrity and Surveillance (OSIS)
OTS | CDER | FDA

Charles Bonapace, Pharm.D., Director
Arindam Dasgupta, Ph.D., Deputy Director
Division of New Drug Bioequivalence and Evaluation
OSIS | OTS | CDER | FDA

FDA Panel for Questions
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.

FDA RESOURCES

Continuing Education Credits

  • This course is eligible for 3.5 CE credits for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE announcement for complete information.
  • This webinar is RAPS eligible for credit towards a participant’s RAC recertification.
  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.

For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707


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