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Agenda

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ABOUT THIS WORKSHOP

This workshop will:

• Describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS)
• Identify the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection
• Provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability (BA) -Bioequivalence (BE) , In Vivo Analytical BA/BE
• Engage attendees to work through case studies representative of the above programs.

INTENDED AUDIENCE

• Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data
• Regulatory affairs professionals who are involved in GLP-regulated nonclinical laboratory studies and Animal Rule study data
• Researchers involved in regulated bioanalysis
• Sponsors planning studies involving bioanalysis
• Industry professionals associated analytical laboratories that involve bioanalysis

TOPICS COVERED

• Overview of Good Laboratory Practice (GLP), Animal Rule (AR), Compliance Programs (CPs) and inspections
• Guidance updates – Pathology Peer Review and Whole Slide Imaging
• OSIS BA/BE Program that includes BA Studies 505(b)2, BE studies, In Vitro BE studies and immunogenicity studies
• Expectations during BA/BE Inspections – Immunogenicity, Clinical CP, Clinical Endpoints and Analytical Studies
• Reserve sample requirements
• Case studies representing the different compliance programs.

FDA RESOURCES

• Regulations
  1. Regulation Part 320 – Bioavailability and Bioequivalence Requirements
• Related Guidance
  1. Bioanalytical Method Validation (BMV) Guidance for Industry
  2. Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
  3. Good Laboratory Practice for Nonclinical Laboratory Studies
• Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations