What You Need to Know About Pharmacovigilance in Novel Hemophilia A Treatment

What You Need to Know About Pharmacovigilance in Novel Hemophilia A Treatment

What You Need to Know About Pharmacovigilance in Novel Hemophilia A Treatment

Discover the ins and outs of the pharmacovigilance process to be sure you’re correctly reporting your patients’ adverse drug reactions.

Available credits: 0.25

Time to complete: 15 minutes


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  • Overview

    Pharmacovigilance begins after clinical trials end and new therapies enter everyday practice. Due to the rarity of hemophilia, participation in clinical trials has necessarily been small, and so monitoring the safety of new hemophilia treatments is especially important. Continued surveillance of adverse drug reactions (ADRs) after approval is a responsibility that falls on all members of the care team.

    Dr. Shannon Meeks and Dr. Cindy Leissinger discuss the importance of safety surveillance and monitoring for novel hemophilia A therapeutics. To give a better understanding of pharmacovigilance, this activity includes animation that breaks down the process and illustrates where your ADR reports go and what happens next.

  • Disclosure of Conflicts of Interest

    In accordance with the ACCME Standards for Commercial Support, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. GLC resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.

    Shannon L. Meeks, MD
    Professor of Pediatrics
    Emory University and Children’s Healthcare of Atlanta
    Atlanta, GA
    Consulting Fees: Genentech

    Cindy A. Leissinger, MD
    Professor of Medicine
    Tulane University
    New Orleans, LA
    Consulting Fees: Genentech

    Reviewers/Content Planners/Authors:

    • Stephen Chavez has nothing to disclose.
    • Ann Early has nothing to disclose.
    • Libby Lurwick has nothing to disclose.
    • Brian P. McDonough, MD, FAAFP has nothing to disclose.
    • Tricia O’Leary has nothing to disclose.
  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • Outline best practices for drug and biologic post-marketing safety surveillance and reporting
    • Describe methods for classifying and reporting adverse drug reactions to local authorities and other stakeholders
    • Review the thresholds for when and where to report ADRs
  • Target Audience

    This activity is designed to meet the educational needs of hematologists, primary care physicians, pediatricians, emergency department physicians, advanced practitioners, nurses, and specialty pharmacists, with a secondary audience including other members of the HTC team, including physical therapists, social workers, orthopedists, dentists, and those providers who see and treat people with hemophilia A.

  • Accreditation and Credit Designation Statements

    Global Learning Collaborative is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Global Learning Collaborative designates this enduring material for a maximum of .25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    ReachMD Healthcare ImageReachMD Healthcare Image

    This CE activity is jointly provided by ProCE, LLC and Prova Education. ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-9999-21-097-H01-P has been assigned to this home study knowledge-based CE activity (initial release date 3-31-2021). This activity is approved for 0.25 contact hour (0.025 CEU) in states that recognize ACPE providers. Completion of the evaluation and the post-test with a score of 70% or higher is required to receive CE credit. Proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given. ACPE requires that CE credit be claimed within 60 days of completion of the post-test and evaluation. There is no fee required for participation in this activity.

    Release Date: March 31, 2021
    Expiration Date: March 31, 2022

  • Provider

    ReachMD Healthcare Image

    Prova Education, designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties. 

    Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the very best education in the most impactful manner and to verify its results with progressive outcomes research. 

  • Commercial Support

    This activity is supported by an independent educational grant from Genentech, Inc.

  • Disclaimer

    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Prova Education. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of Prova Education you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.

    Reproduction Prohibited

    Reproduction of this material is not permitted without written permission from the copyright owner.

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