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Overview

The workshop will cover the key disclosure and transparency requirements and background information on how the requirements have evolved from 2004-2018. The topics to be covered are:

  • The evolution from ICMJE requirements in 2004 to today’s requirements for sharing of clinical study documents in relation to regulatory submissions.
  • Who are the outside influencers and the internal stakeholders
  • A deeper dig into the EU and US requirements, similarities and differences
  • Highlights of the FDA Amendments Act Final Rule expanding reporting requirements in ClinicalTrials.gov
  • The global environment of local and primary WHO registers
  • A few words as to the future requirements – a teaser for the topics to be covered during the conference

Download Programme

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Who should attend?

People relatively new to the disclosure and transparency area.

People working with:

  • Disclosure, Trial and Results Registration Activities
  • Publications
  • Medical Writing
  • Regulatory Submissions

Audience with limited or beginner’s knowledge of the disclosure requirements.

Program Committee

  • Merete  Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
    Novo Nordisk A/S, Denmark
  • Robert  Paarlberg, MS, MSc
    Robert Paarlberg, MS, MSc Principal
    Paarlberg & Associates LLC, United States
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