3 - PPH plus webinars:

• QbD & Risk-based Approach in Clinical Trials (17 November 2016)
• ICH GCP Goes Risk-based (7 April 2016)
• RbM: from Idea to Implementation (21 April 2016)

4 - Other PPH plus articles concerning Quality by Design, Risk-based Quality Management (RBQM) and Risk-based Monitoring (RBM) by PPH plus:

• Are Preventive Approaches to Clinical Trial Quality Management Cost-Effective? (LinkedIn, 15 February 2017)
• Quality Review (International Clinical Trials, autumn 2015)
• ICH GCP Goes Risk Based – GCP Addendum Review and Embracement Plan (Applied Clinical Trials Online, 27 October 2015)
• RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management (Applied Clinical Trials Online, 13 January 2015)

5 - Relevant regulatory guidelines:

• Risk proportionate approaches in clinical trials. Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. European Commission (EC), 25 April 2017
• Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (draft version). European Medicines Agency (EMA), 31 March 2017
• Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (draft version). European Medicines Agency (EMA), 31 January 2017
• ICH Harmonized Guideline - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). International Council for Harmonisation (ICH), 9 November 2016
• Reflection paper on risk based quality management in clinical trials. European Medicines Agency (EMA), 18 November 2013
• Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), August 2013
• Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4). International Conference on Harmonisation (ICH), 11 November 2010
• ICH Harmonized Tripartite Guideline - Pharmaceutical Development Q8(R2). International Conference on Harmonisation (ICH), August 2009
• ICH Harmonized Tripartite Guideline - Pharmaceutical Quality System Q10. International Conference on Harmonisation (ICH), 4 June 2008
• ICH Harmonized Tripartite Guideline - Quality Risk Management Q9. International Conference on Harmonisation (ICH), 9 November 2005

6 - Other relevant initiatives:

• ADAMON project- Risk ADApted MONitoring. Project funded by the German Federal Ministry of Education and Research (BMBF).
  Project led by the ZKS Leipzig in collaboration with the network of Coordination Centres for Clinical Studies (KKS Network), Competence Networks in Medicine (KN) and the German Federal Institute for Drugs and Medical Devices (BfArM).
  Published results (Oana Brosteanu, Gabriele Schwarz, Peggy Houben et al. "Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study". Clinical Trials, 8 August 2017)
• TransCelerate RBM assets
• CTTI Quality by Design Project - Critical to Quality (CTQ) Factors Principles Document. Clinical Trials Transformation Initiative (CTTI), 19 May 2015
• OPTIMON study: OPTImisation of MONitoring. Centre Hospitalier Universitaire de Bordeaux (France), 8 February 2008
• Metrics Champion Consortium