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:

The importance of adverse event (AE) reporting throughout the medical device product development process will be discussed. Focus will be on how individual patient adverse events (AE) become integral to final product labeling.

Topics:

1. Direct-to-consumer drug commercial
2. Adverse Event “Journey”
   • Individual patient adverse event on Case Report Forms (CRF)
   • Clinical Study Report (CSR)
     • ICH E3 Guideline for the Content and Format of CSR
   • Integrated Summary of Safety (ISS)
     • 21 CFR 314.50
   • Indication in Clinical Safety Summary
3. Adverse Event /Safety Information: FDA review of a commercial drug example
   • Adverse event of special interest
   • Benefit risk assessment
   • Prescribing information
   • Partial adverse event – Listed in prescribing information
4. Common technical document pyramid
5. Purpose of prescription drug product labeling

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

Audience:

This course is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Learner Level: Beginner

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 0.5 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

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

Program Information: This is the sixth (6^th) and final course in a six (6) course program. To complete the entire program and earn a badge CLICK HERE.