Clinical Trial Disclosure and Data Transparency Conference

This first session on Access to Regulatory Documents will focus on the regulators’ perspectives while highlighting similarities and differences among the different approaches in EU, US, and Canada. A proactive approach to access to regulatory clinical documents submitted under the centralized procedure has been implemented by EMA’s launch of a specific website. EMA has issued further guidance on the implementation of its Policy 0070 - EMA/240810/2013, and EMA/90915/2016. In March 2017 Health Canada published its intent of a similar approach in the Public release of Clinical Information in Drug Submissions and Medical Device Applications.