Mercure Amsterdam City Hotel

May 29, 2024 8:00 AM - May 30, 2024 4:30 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Pharmacovigilance Strategies Workshop

Collaborate and Innovate for Patient-Centric Safety.

Overview

The DIA Pharmacovigilance (PV) Strategies Workshop is a unique platform for PV professionals to interact, share experiences, and learn in a neutral environment. Engage in rich discussions with a diverse group of stakeholders, including regulators, industry, trade associations, patients, academia, and solution providers.

This workshop format offers thought-provoking dialogue that explores a range of topics, from ethics to emerging technologies. Key regulators in the pharmacovigilance space, including EMA and National Competent Authorities, will be represented in these discussions.

Discover how to apply the latest cutting-edge strategies and solutions in your organisation and daily work to boost your PV performance. Real-world-application, accessibility to experts, and a mix of representatives make this workshop an invaluable opportunity for any PV professional.

You can also expect:

Think Tank Session: As part of the agenda, you will have the chance to join a collaborative workshop on the topic of 'Building Pharmacovigilance Regulations/GVP'. Using a design-thinking framework, you will collaborate in multi-stakeholder teams to build a revolutionary vision for GVP and develop concrete next steps.

Featured topics

    Participants interested in:

  • Understanding the Current Regulatory Landscape in Pharmacovigilance, including GVP Updates.
  • Strategies for Ensuring Compliance.
  • Leveraging Patient Registries for Safety Monitoring.
  • Ethical Dimensions in Pharmacovigilance.
  • Implementation of Digital Tools for Risk Minimisation.
  • Real-World Data (RWD), Real-World Evidence (RWE), and its Applications in Pharmacovigilance.

Featured

Want to learn more about Pharmacovigilance Strategies Workshop? You've come to the right site!

Exhibits

Who should attend?

  • Established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance, including:

    • Signal Management
    • Data Privacy
    • Risk Management Planning
    • PSMF maintenance
    • Clinical Trials

 

Professionals involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Benefit-risk assessment and communication
  • Medical Product Safety Assessment
  • Regulatory Intelligence
  • Clinical Trials
  • Pharmaceuticals, biologics, combination products, devices
  • Clinical Research and Clinical Research Organizations
  • Pharmacoepidemiology
  • Academic Research Centers
  • Regulatory Agencies

Learning objectives

  • Upon completion, learners should be able to:

    • Navigate the PV Landscape: Acquire a clear understanding of the current regulatory landscape in PV.
    • Have Success with Compliance: Gain insights into and explore best practices to successfully achieve compliance.
    • Embrace Patient-Centricity: Learn how to implement remote patient monitoring in a patient-centric PV approach.
    • Harness the Power of Patient Registries: Discover how to optimally use patient registries to further characterise safety concerns for new innovative medicines.
    • Digitalise for Efficiency: Learn how to overcome potential challenges in digitalising risk minimization measures for a more efficient PV system.
    • Engage and Collaborate: Connect with peers, regulators, and experts in an interactive format, and get answers and advice for your business challenges.
    • Think Beyond the Routine: Go beyond everyday responsibilities to understand regulators’ expectations and ensure your PV work aligns with these expectations, and delivers efficient outcomes for patients.

Program Committee

  • Francoise  Sillan, MD
    Francoise Sillan, MD EU1 UK QPPV
    Ipsen, France
  • Wendy  Huisman, PharmD
    Wendy Huisman, PharmD Director
    Vigifit, Netherlands
  • Shahin  Kauser
    Shahin Kauser Leading Senior Scientific Assessor
    MHRA, United Kingdom
  • Maarten  Lagendijk, MSc
    Maarten Lagendijk, MSc Deputy EU QPPV
    MSD, Netherlands
  • Willemijn  van der Spuij, MSc
    Willemijn van der Spuij, MSc Executive Director Europe WorldWide Patient Safety
    Switzerland
  • James  Whitehead, MBA, MSc
    James Whitehead, MBA, MSc Senior Director, Device & Digital Safety
    AstraZeneca, United Kingdom
  • Esther  De Vries, MS, MSc
    Esther De Vries, MS, MSc Assessor Pharmacovigilance
    MEB, Netherlands

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