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Overview

September 13: Short Courses*
September 14-15: Conference

Short Course 1: Disclosures 101
This preconference training is designed for professionals new to clinical trial disclosure operations.

Short Course 2: Preparing Documents for Disclosure and Public Sharing
This preconference training is appropriate for medical writers who will be preparing documents for disclosure.

*Short Courses require separate registration.


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 and the EU. With evolving requirements comes a host of new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This conference will provide critical and timely information relating to clinical trial disclosure and data transparency from those on the front lines. It will highlight major recent regulatory changes and other related hot topics to clinical trial disclosure information transparency, including implementation of the US Final Rule, EMA Policy 0070, EMA policy 0043, data sharing, and lay language summaries. Engage with speakers who will provide expert insight into how study sponsors from industry, academia, and government are addressing these changes and putting them into practice.

Take a look at our Preliminary Schedule At-A-Glance.

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.




Highlights

  • NEW - Engage with the DIA CTD community at the open meeting
  • NEW- Poster session and oral abstract presentations
  • Keynote Address from Michael S. Lauer, MD, FACC
  • Hear firsthand from colleagues from ClinicalTrials.gov and the EMA on regulatory changes
  • Patient-level data sharing of best practices, challenges, and data protection
  • Exclusive short courses to enhance your learning experience
  • Exhibits to learn about the latest solutions and services

Who should attend?

Professionals involved in:

  • Compliance
  • 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

Learning objectives

At the conclusion of this conference, participants should be able to:

  • Explain present and upcoming requirements for clinical trial disclosure and data transparency requirements globally
  • Identify IT systems and tools that can facilitate clinical trial data disclosure compliance
  • Describe best practices for operationalizing new provisions to be compliant with the new regulations for clinical trial disclosure and data transparency

Program Committee

  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States
  • Marla Jo  Brickman, PhD
    Marla Jo Brickman, PhD Senior Director - Clinical Data Transparency/Compassionate Access Lead
    Pfizer Inc, United States
  • Merete  Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Director, Global Clinical Registry
    Novo Nordisk A/S, Denmark
  • Erik  Lakes, MS, MSc
    Erik Lakes, MS, MSc Associate Director, Global Clinical Study Disclosure
    Takeda Pharmaceuticals, Inc., United States
  • Melanie  North, PhD
    Melanie North, PhD Consultant
    Melanie North Consulting, United States
  • Patricia A. Teden, MBA
    Patricia A. Teden, MBA President and Principal
    Teden Consulting LLC, United States
  • Matthias  Zerm, PhD
    Matthias Zerm, PhD Lead Expert Clinical Trial Disclosure and R&D Processes
    Merz Pharmaceuticals GmbH, Germany
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Contact us

Customer Service

1.888.257.6457


Short Course 1

Disclosures 101


Short Course 2

Preparing Documents for Disclosure and Public Sharing 


DIA's Clinical Trial Content Toolkit

View Here


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