1. https://www.novartis.com/sites/www.novartis.com/files/novartis-annual-report-2018-en.pdf
  2. Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice, June 2015
  3. Commission Directive 2005/28/EC
  4. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
  5. Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006