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Agenda COMING SOON

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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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who 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.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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