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DoubleTree Bethesdan

Sep 19, 2019 7:00 AM - Sep 20, 2019 3:15 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Overview

Short Courses: September 18
Conference: September 19-20

Clinical trial information transparency is taking on new dimensions. Clinical trial sponsors and academia are facing a host of new registration requirements in the US, EU, and elsewhere. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This conference will provide critical and timely information relating to global clinical trial disclosure and data transparency from those on the front lines.

NEW! This year's conference will have an even greater global presence than ever!

Check out our 2019 Program!

On-Demand Webinar

EU Device Regulations – The European Database on Medical Devices (Eudamed)
The EU’s 2017 passage of new medical device regulations presents substantial changes in how clinical trials of medical devices are disclosed in the EU, from protocol approval to the reporting of summary results. In 2020, Eudamed will provide the public with a comprehensive view of medical device research and approvals throughout the EU. This webinar will look at the new EU requirements and discuss how sponsors can approach meeting them.
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Continuing Education

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Exhibits

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Highlights & Features

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Who should attend?

Professionals involved in:
  • 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

At the conclusion of this workshop, participants should be able to:
  • Discuss best practices to achieve good compliance
  • Assess the operational challenges and considerations in executing Innovative Trial Designs
  • Describe the changes in EudraCT and the practical implications
  • Describe the current status of Clinical Data Summary Pilot Program and any findings related to the program implementation to date

Short Course or Primer

To keep you at the forefront.

Sep 18, 2019

Short Course 1:

Clinical Trial Disclosure 101

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Sep 18, 2019

Short Course 2:

Practical Approaches to Using the ClinicalTrials.gov PRS

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Program Committee

  • Robert Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States
  • Suzanne Carlson, MA
    Suzanne Carlson, MA Consultant
    ABSD Associates, LLC, United States
  • Kelly Coulbourne, MS
    Kelly Coulbourne, MS Director, Clinical Trial Disclosure and Data Transparency
    Pfizer Inc, United States
  • Patrick Fawcett
    Patrick Fawcett Information Disclosure Administrator, Office of Research Protections
    University of Pittsburgh, United States
  • Merete Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
    Merete-J Consulting CVR: 34920818, Denmark
  • Francine Lane, MBA
    Francine Lane, MBA Senior Director of Product Management
    Citeline, United States
  • Nate Root, MSc
    Nate Root, MSc Associate Director, Disclosure and Transparency
    Ionis Pharmaceuticals, United States

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