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Hilton London Docklands Riverside Hotel

Sep 18, 2018 12:00 PM - Sep 18, 2018 5:00 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Workshop: The Evolving Disclosure/Transparency Landscape


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
  • 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

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In 2018, DIA is going paperless. No printed programme will be distributed onsite, so please make sure to download the app in advance.
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  • Integrate with your social media accounts

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 Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
    Merete-J Consulting CVR: 34920818, Denmark
  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States

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