SBIA | Registration Open for Clinical Investigator Training Course (CITC) Update

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Clinical Investigator Training Course (CITC) Update December 7 - 8, 2021 Day 1: Tue, Dec 7 1:00 PM - 5:00 PM ET Day 2: Wed, Dec 8 1:00 PM - 4:30 PM ET This virtual course is free. Registration    Agenda   Add to Calendar The U.S. Food and Drug Administration's Clinical Investigator Training Course (CITC) has been conducted in person for more than ten years. Unfortunately, due to the pandemic, it was postponed in 2020. Given ongoing concerns about COVID-19, this year will be an abbreviated, virtual update rather than a full course.  We are hopeful that the full course will resume in 2022. LEARNING OBJECTIVES Explain the scientific and regulatory challenges related to gene therapy and Cart therapy Review the development of medical products for the prevention and treatment of Covid-19 Describe the responsibilities of an investigator conducting a clinical trial Describe innovative approaches to the conduct of clinical trials TOPICS Gene Therapy and CarT Therapy Medical Products for the Prevention and Treatment of COVID-19 Emergency Use Authorizations for COVID-19 Trial Approaches including Master Protocols, Decentralized Clinical Trials, Digital Health Technologies, and use of Real-World Data/Evidence Drug Repurposing Diverse Representation in Clinical Trials Investigator Responsibilities including as applied during COVID-19 WHO SHOULD ATTEND? To maximize the value of this update, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements for conducting those trials, and medical product development. The following are some categories of professionals who may benefit the most from the update: Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists) Consultants Drug, device, and biologic industry employees Regulatory affairs professionals Biomedical professionals This course is part of the SBIA Regulatory Education for Industry (REdI) series. 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 credits (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. has been 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. has been 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. has been 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. 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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