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Baltimore Marriott Waterfront

Feb 05, 2024 7:00 AM - Feb 07, 2024 1:00 PM

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Overview

Short Course: January 24, 2024 | Virtual

Short Course: February 4, 2024 | In-Person

Short Course: February 27, 2024 | Virtual

Conference: February 5-7, 2024 | In-Person

DIA's Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals.

 

Participant Testimonials

Informative, collaborative, professional, organized. – Participant

The topics are very relevant to the hot discussions going on right now in the industry, and there is a lot of cross industry experience to learn and discuss these topics. – Participant

It covers wide range of safety related topics, for all levels. And it encourages new learnings. It will give everyone an excellent opportunity to brash up skills. – Participant

Keynote Address!

February 5 | 8:40AM-9:25PM

Keynote Address

Session 1: Keynote: Personalized Medicine and the Pharmaceutical Industry

The Keynote has Been Released! Michael Ybarra, MD, Chief Medical Officer, PhRMA

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Highlights & Features

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Today’s Baltimore is a place where good ideas and ambition are the currency that matter most. It’s a place where art is seen as a catalyst for conversation, food as a means of connection, and history as an opportunity for education. It’s an essential destination full of inclusive neighborhoods where all visitors will feel invited, welcomed, and seen. Click here to check out all the tour guides based on your interests.

Discover Baltimore!

Who should attend?

  • Meeting Designed for

    • Drug Safety
    • Pharmacovigilance
    • Risk Management
    • Benefit-risk Assessment and Communication
    • Medical Product Safety Assessment
    • Post-Market Studies
    • Real-World Evidence Generation
    • Regulatory Affairs
    • Clinical Research
    • Data Safety Monitoring and Analysis
    • Pharmacoepidemiology
    • Medical Information
    • Medical Communications
    • Medical Affairs
    • Health Outcomes
    • Patient Engagement

Learning objectives

  • At the completion of this conference, the participant should be able to:

    • Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
    • Discuss safety regulatory updates in the U.S, U.K, Europe, Japan, and China
    • Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities
    • Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry
    • Identify new signal detection tools and reinforce the FMQ method and analysis
    • Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials
    • Describe challenges to establishing global approaches to risk minimization and identify risk analysis approaches to developing risk minimization materials
    • Analyze recent advances in the use of AI/ML with respect to safety surveillance
    • Identify the latest strategies for managing literature requirements at local and global level
    • Examine various ways RWE/RWD are utilized in regulatory interactions during clinical development and its role in the evaluation of safety signals arising from clinical trial data
    • Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities
    • Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials
    • Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials

Short Course or Primer

To keep you at the forefront.

Jan 24, 2024

Short Course:

Introduction to Statistics in Pharmacovigilance

Feb 04, 2024

Short Course:

Aggregate Safety Assessment Planning (ASAP) Process

Feb 27, 2024

Short Course:

Good Pharmacovigilance Practices (GVP) Operations Development – From Clinical Trial to Post Marketing

Program Committee

  • James  Buchanan, PharmD
    James Buchanan, PharmD President
    Covilance LLC, United States
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Safety Officer
    Bristol-Myers Squibb Company, United States
  • Barbara  Hendrickson, DrMed, MD
    Barbara Hendrickson, DrMed, MD Clinical Associate, Pediatric Infectious Diseases
    University of Chicago, United States
  • Scott  Janiczak, PharmD, MPH
    Scott Janiczak, PharmD, MPH Safety Evaluator, LCDR, Division of Pharmacovigilance I, OSE, CDER
    FDA, United States
  • Mamiko  Kasho
    Mamiko Kasho Executive Director, Global PV Management Dept., Global Safety HQs
    Eisai Co., Ltd., Japan
  • Susan  Kindig, JD, MD
    Susan Kindig, JD, MD Prior Executive Director, Medical and Drug Safety
    United States
  • Mengchun  Li, MD, MPA
    Mengchun Li, MD, MPA Senior Director, Clinical Research, Infectious Disease
    Merck & Co., Inc., United States
  • Joseph  Paradis, PharmD
    Joseph Paradis, PharmD Associate Director for Medication Error and Risk Management Initiatives, CDER
    FDA, United States
  • Mark  Perrott, PhD
    Mark Perrott, PhD Managing Partner
    Axian Consulting Ltd., United Kingdom
  • Sarah  Vaughan
    Sarah Vaughan Head of Vigilance Operations
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Yijing (Hellen)  Zhang, MPharm
    Yijing (Hellen) Zhang, MPharm Executive Director, Global Patient Safety
    Beigene, China
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President and Head, Safety Evidence and Sciences
    Bristol-Myers Squibb Company, United States
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States

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