The FDA is offering a free clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign). The two-day (Wednesday, December 7, 2022 – Thursday, December 8, 2022) course is designed for clinical investigators, healthcare professionals (physicians, nurses, pharmacists, and other healthcare workers), and individuals involved in biomedical research and the development of medical products.

ABOUT THIS CONFERENCE

This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.

TOPICS COVERED

• Design and conduct of clinical trials
• Determining appropriate endpoints in clinical trials
• Efforts to advance diversity in trial populations
• Statistical evaluation of clinical trials
• Innovative trial designs
• Interpretation of the investigator brochure
• Clinical trial quality

INTENDED AUDIENCE

This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.

FDA RESOURCES

• Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biologic Products Guidance for Industry – Draft Guidance
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products – Draft Guidance
• Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations – Draft Guidance

CONTINUING EDUCATION

This course has been approved for 7.75 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. Each day after the course concludes, that day’s attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.

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.