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  5. FDA Grand Rounds – Pharmacovigilance in Practice: From Safety Signals to Regulatory Action - 05/14/2026
  1. FDA Grand Rounds

Webcast | Virtual

Event Title
FDA Grand Rounds – Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
May 14, 2026

Date:
May 14, 2026
Time:
12:00 p.m. - 1:00 p.m. ET

To Attend

For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov or Ayan.Ibrahim@fda.hhs.gov.

Speakers

LCDR Anne Tobenkin, Pharm.D., M.S.

LCDR Anne Tobenkin, Pharm.D., M.S.
Safety Evaluator 

Leah Herity, Pharm.D., M.P.H.

Leah Herity, Pharm.D., M.P.H.
Safety Evaluator

Division of Pharmacovigilance 
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

About the Speakers

LCDR Anne Tobenkin serves as a safety evaluator on the neurology team in the FDA's Division of Pharmacovigilance (DPV) within the Center for Drug Evaluation and Research. With over 20 years of specialized experience in postmarket safety surveillance and evaluation, she plays a critical role in protecting public health through comprehensive drug safety monitoring. LCDR Tobenkin earned her Doctor of Pharmacy from Albany College of Pharmacy in 2003 and a Master of Science from the University of Maryland in 2022. She began her career as a primary care pharmacist at the Veterans Affairs Hospital in Washington, D.C., before joining the FDA in 2008. At the FDA, she initially served as a safety evaluator in the Division of Medication Error Prevention and Analysis, then advanced to DPV where she conducted adverse event surveillance for anticoagulants and multiple sclerosis drug products. She subsequently transitioned to the Office of Compliance, specializing in misbranded and unapproved prescription drug products. Most recently, she served as a team leader in the Office of New Drugs, where she supported the implementation and management of postmarketing safety initiatives, including developing and leading a postmarket safety report pilot program.

Leah Herity joined the FDA in 2022 as a safety evaluator in the Division of Pharmacovigilance within the FDA’s Center for Drug Evaluation and Research, where she has contributed to multiple complex postmarketing safety reviews and high-impact regulatory actions. She earned a Bachelor of Science in biological sciences from the University of Connecticut in 2009 and a Doctor of Pharmacy and Master of Public Health in Public Health Leadership from the University of North Carolina at Chapel Hill in 2018. After graduating, she continued her training at Virginia Commonwealth University Health System in Richmond, Virginia, where she completed a PGY1 residency in pharmacy practice, PGY2 residency in internal medicine pharmacy, and received board certification as a pharmacotherapy specialist. Prior to joining FDA, she was an Assistant Professor of Pharmacy Practice at Albany College of Pharmacy and Health Sciences and clinical pharmacist in inpatient family medicine at St. Peter’s Hospital in Albany, New York.

About the Presentation

This lecture will discuss the Division of Pharmacovigilance’s drug safety activities within the FDA's Center for Drug Evaluation and Research. The lecture will focus on how the FDA identifies, evaluates, and responds to postmarket safety concerns and includes three recent safety findings that resulted in regulatory actions.

Learning Objectives

  1. Describe the process of pharmacovigilance at the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).
  2. Discuss three important safety updates that FDA recently issued. 
  3. List regulatory actions that the FDA can take to communicate new safety findings.
  4. Explain how to submit a MedWatch report.

Continuing Medical Education (CME) Credit

As CME credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CME credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CME credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation. 

Accreditation Statement

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Johns Hopkins University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This regularly scheduled series has been approved for a 52-week cycle beginning October 23, 2025.

Other Credits

Reciprocity exists with the following boards that accept AMA PRA Category 1 Credits™ from organizations accredited by the ACCME:

  • American Nurses Credentialing Center 
  • American Academy of Nurse Practitioners National Certification Program 
  • National Commission on Certification of Physicians Assistants 
  • Psychologists: JHUSOM is authorized by the Maryland State Board of Examiners of Psychologists as a provider of continuing education. The JHUSOM maintains responsibility for this program.
  • Social Workers: The Maryland Board of Social Work Examiners certifies that this program meets the criteria for 1 credit hour of Category 1 of continuing education for social workers licensed in Maryland. The JHUSOM is an approved sponsor of the Maryland Board of Social Work Examiners for continuing education credits for licensed social workers in Maryland.

These professionals should submit their transcript to their respective boards to convert their credits to CEUs.

Policy on Presenter and Provider Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the presenter globally disclose conflicts of interest and any discussion of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place to identify and mitigate relevant conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education.

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