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Overview

The 2020 Conference builds on prior very successful conference series and leverages learnings from Regulators and international experts in the field. Clinical trial sponsors and academia are facing a host of new registration requirements in the EU, USA, and elsewhere. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This event will provide essentials and timely information about global clinical trial disclosure and data transparency. It brings leading study sponsors from Industry and Academia to exchange knowledge and share their experiences with the implementation of Clinical Trial and Data Transparency from an academic and an industry viewpoint.

Featured topics

• Approaches to navigating and complying with global disclosure and transparency requirements
• Upcoming implementation of the EU Clinical Trial Regulation: CTIS Status/Updates
• Legal requirements related to disclosure of clinical research information for medicinal products and medical devices
• The data sharing requirements and initiatives
• Impact of the EU General Data Protection Regulation (GDPR) on data sharing
• Latest developments from ClinicalTrials.gov and Health Canada
• Patient Perspective
• Global harmonisation – benefits and barriers
• Compare and contrast qualitative and quantitative data anonymisation techniques for sharing of individual participant data
• Learnings for the future from COVID-19

Who should attend?

        • Compliance/Legal
        • Clinical trial disclosure
        • Transparency policies and compliance
        • Clinical operations
        • Medical writing, medical affairs, and medical communications
        • Regulatory
        • Publications
        • Biometrics
        • Data management
        • Disclosure
        • Data transparency/data sharing
        • Academia
        • Clinical/Medical Research
        • Patient Advocacy

Learning objectives

• Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large to smaller sponsor organisations

• Leverage best practices on the practical implementation through case studies by the exchanging of views between regulators, industry, patients, academia and other stakeholders

• Use a unique opportunity for networking and asking questions to your own specific situation and area of responsibility

 

Program Committee

  • Merete  Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Senior Director, Clinical Transparency
    Novo Nordisk A/S, Denmark
  • Scott  Feiner
    Scott Feiner Senior Project Manager, Disclosure
    AbbVie, United States
  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States
  • Nate  Root, MSc
    Nate Root, MSc Associate Director, Disclosure and Transparency
    Ionis Pharmaceuticals, United States
  • Matthias  Zerm, PhD
    Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
    Merz Therapeutics, Germany
  • Julie G. Holtzople
    Julie G. Holtzople Head of Clinical Transparency and Data Sharing
    AstraZeneca, United States
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Contact us

Trouble connecting on the day of the event?

Send Email
+41 61 225 51 51


Registration Questions?

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+41 61 225 51 51


Preconference Tutorials

Workshop: Best Practices for the Redaction and Anonymization of Clinical Documents

 

Digital Learning Catalog

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