Webinars and Virtual Workshops

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Webinars and Virtual Workshops Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. Date: May 27, 2020   Time: 12:15 PM - 1:15 PM ET Registration is not required. Webinar: Monograph reform is here! Learn what to expect and how to prepare. This webinar provides a general overview of monograph reform, how it impacts FDA’s regulation of monograph products, and how it affects industry and the public. The webinar will address most commonly asked questions. Date: May 29, 2020  Time: 1:00 PM - 2:00 PM ET To register for this Webinar, please visit the registration page. Register Here

Webcast Lecture: Streamlining Genetic Safety Analysis for Ex Vivo Genome Edited Cell Therapies Genome editing is an emerging and exciting new technology that is being discussed as a potential method to treat a range of diseases that have large unmet medical needs. This lecture will discuss the process of generating data to assess which methods of identifying potential off-target sites using the CRISPR/Cas9 system identify bona fide off-target sites using clinically relevant ex vivo genome editing reagents. Date: June 2, 2020     Time: 3:00 PM - 4:00 PM ET Registration is not required. Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference - Organized by FDA in Collaboration with the Clinical Trials Transformation Initiative (CTTI) This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Members of the EWG will provide an overview of the ongoing work to update the guideline and will then hear from multiple stakeholders on their experiences with ICH E6(R2). Date: June 4 - 5, 2020    Time: 10:00 AM - 1:00 PM ET To register for this Web Conference, please visit the registration page. Register Here