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Pharmacovigilance & Safety: Regulatory Requirements

1 credit


Full course description

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.


Pharmacovigilance terminologies and adverse event definitions for drugs and medical devices will be reviewed.The adverse event reporting procedures and FDA requirements for drugs and medical devices during product development and post-marketing will be examined.

Course Topics

  1. Definitions
    • Pharmacovigilance
    • Adverse Event (AE)
    • Adverse Reaction (WHO)
    • Serious Adverse Event (SAE)
    • Suspected Unexpected Serious Adverse Reaction (SUSAR)
  2. The “S” factors: Serious, Suspected, Severity
  3. Safety Reporting Regulations: Drugs and Biologics
    • U.S. Requirements for Safety Reporting for Investigational Drugs/Biologics (21CFR312.32)
    • U.S. Requirements for Safety Reporting for Marketed Drugs (21CFR314.80) / for Marketed Biologics (21CFR600.80)
  4. Medical Devices Report (MDR) Requirements and Terminology
    • Device Reporting Chart
  5. Pre-Marketing AE Reporting
  6. Post-Marketing AE Reporting
    • Adverse Drug Experience (ADE)
  7. SUSAR Reporting
  8. How to Submit – Industry
    • 3500A MEDWATCH Form
    • Council for International Organizations of Medical Sciences (CIOMS) Form
  9. U.S. IND Safety Reports
  10. Determining Drug Relationships/Causality
  11. Guidance for Industry (Dec 2015): Safety Assessment for IND Safety Reporting
  12. AE Reporting via IND Annual Reports
  13. Period Safety Reports


Nancy Smerkanich, DRScMS, 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.


Beginner/Intermediate:This course is designed for Clinical Research Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with at least 1-3 years of clinical research experience.

Learner Level: Beginner/Intermediate

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 1.0 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at or 404-727-9208.

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



Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz 

·       Complete the evaluation at the end

Certificates will be distributed at the end of the evaluation.


Enduring Materials Dates:


·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027

Sign up for this course today!