EU Clinical Data Transparency

September 15, 2017 10:00–11:00 Eastern Time (US & Canada)

The EMA Policy 0070 entered into force at January 2015. As a result, initial MAAs, extensions of indications and Article 58 submitted as of 2015 are subject to clinical data transparency. Both, clinical reports and individual patient data are both referred to as ‘clinical data’. This webinar will introduce you to:
1. objectives
2. practical aspects of redacting clinical reports with Commercially Confidential Information (CCI) and Protected Personal Data (PPD)
3. practical aspects of the justification table for CCI
4. submissions in the eCTD lifecycle
5. Q&A

Presenter: Maikel Bouman, Regulatory Operations Manager, Qdossier B.V., The Netherlands
Co-presenter: Hans van Bruggen, Owner and Senior Regulatory Affairs Scientist at Qdossier/eCTDconsultancy

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