SBIA Webinar: Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies This on-demand webinar is now available.  View Webinar FDA is providing background on investigational new drug (IND) safety reporting and will introduce listeners to the new guidance Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.  Learn about new content covered in this guidance.  Topics History and overview of 2010 IND Safety Rule and Related Safety Reporting Guidance Reporting & Aggregate Analyses: Considerations & Methods Pooling Data Across Studies Aggregate Analyses: Reporting Thresholds Entity(ies) Who Should Review Safety Information Unblinding of Safety Data and Implications Safety Surveillance Plan IND Safety Reporting for Marketed Drugs and Active Control Electronic reporting using ICH E2B standards AUDIENCE Sponsors of IND or BA/BE clinical trial studies Clinical investigators of IND or BA/BE clinical trial studies Contract Research Organizations working for Sponsors of IND or BA/BE clinical trial studies Institutional Review Boards for IND or BA/BE clinical trial studies The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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