SBIA | Office of Study Integrity and Surveillance Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
Registration is now open! Agenda coming soon.
FDA | CDER | Small Business and Industry Assistance
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.
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.
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
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 workshop is:
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.
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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