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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Sep 14, 2017 7:00 AM - Sep 15, 2017 3:00 PM

1750 Rockville Pike, , Rockville, MD 20852 , USA

Clinical Trial Disclosure and Data Transparency Conference

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

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.


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

Featured

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Continuing-Education

Exhibits

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

Short Course or Primer

To keep you at the forefront.

Sep 13, 2017

Course 1:

Disclosures 101

Sep 13, 2017

Course 2:

Preparing Documents for Disclosure and Public Sharing

Program Committee

  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    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 Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
    Merete-J Consulting CVR: 34920818, Denmark
  • Erik  Lakes, MS, MSc
    Erik Lakes, MS, MSc Senior Director and Head, Data Disclosure & Transparency
    Beigene, United States
  • Melanie  North, PhD
    Melanie North, PhD Manager, Clinical Trial Transparency and Disclosure
    United States
  • Patricia  Teden, MBA
    Patricia 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
    Germany

Digital Learning Catalog

DIA Learning: eLearning Soultions
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Clinical Trial Fundamentals eLearning Program

This program follows the activities of a fictitious clinical investigator and her staff as they prepare for, initiate and conduct a clinical study.
Learn More

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

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