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AGENDA

REGISTER

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ABOUT THIS EVENT

This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Participants will acquire a practical understanding of:

• FDA’s approach to trial design
• Safety concerns in the development of medical products
• Statistical issues in the analysis of trial data
• Clinical investigator responsibilities

INTENDED AUDIENCE

This is a clinical investigator training course targeted at all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign). The agenda is designed for:

• Clinical investigators
• Health care professionals (physicians, nurses, pharmacists, other healthcare workers), and
• Individuals involved in biomedical research and the development of drugs and biological products.

TOPICS COVERED

• Design and conduct of clinical trials
• Innovative trial designs
• Considerations for rare disease drug development
• Enhancing diversity in clinical trials
• Addressing specific populations in drug development
• Statistical evaluation of clinical trials
• Understanding the investigator brochure
• Clinical trial quality

FDA RESOURCES

• Draft Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Final Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

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 a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• 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.
• 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.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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