The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

An overview of the history, terms, and definitions of patient focused drug development and real-world data (RWD) and real-world evidence (RWE) will be reviewed.The FDA’s pivotal role in passing the Prescription Drug User Fee Act, the 21^st Century Cures Act, and the Framework for the Real-World Evidence (RWE) and Real-World Data (RWD) Program will be highlighted. The impact on medical product developers utilizing RWE/RWD to support clinical trial designs and observation studies to generate innovative, new treatment approaches will be discussed.

Topics:

1. Acts and regulations guiding patient-centered drug development:
   • Prescription Drug User Fee Act (PDUFA) Amendment
   • Patient Focused Drug Development and Guidance Document
   • 21^st Century Cures Act
   • Real-World Evidence (RWE) Program
2. Randomized Controlled Trials (RCTs) and Real World Data/Evidence
3. Clinical Trials Transformation Initiative (CTTI): Large Simple Trials (LST)
4. Pragmatic Clinical Trials (PCTs)
5. Validity: RCT vs. PCT
6. Framework for FDA’s Real-World Evidence Program
   • Data reliability and relevance
   • FDA digital tool for RWD capturing: MyStudies APP
7. RWD possibilities
8. Key Elements:Provenance, Lineage, Integrity

Speaker:

Nancy Smerkanich, DRSc, MS, is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC).Dr. Smerkanich received her faculty appointment after successfully completing her Doctoral Dissertation on “Benefits Risk Frameworks –Implementation in Industry” in 2015.  In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. Nancy brings many years of practical regulatory knowledge and experience to academia where she participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA).With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Prior to joining Octagon, Dr. Smerkanich held various Regulatory Affairs positions within industry, including nine years at Merck and seven years as an independent consultant. Dr. Smerkanich holds a Doctorate and Master’s degree in Regulatory Science from USC and Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut. piresmer@usc.edu

Learner Level: Intermediate/Advanced

Audience:

Advanced: This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.25 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.