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

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