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Partnerships in Clinical Trials EU

November 28-29, 2017

RAI Exhibition and Convention Centre, Amsterdam




STREAM 4: Governance, Oversight and Quality

Tuesday, 28 November 2017 14:35 – 15:15

Focus on operational risk based approaches to oversight and quality management with the new ICH E6R2 guidelines – How to interpret this and how are companies dealing with it?

  • What do you do to achieve FFP (fit for purpose) effective sponsor, CRO and third party oversight in light of the ICH E6 and what does it look like?
  • Evaluate whether the perceptions of quality in outsourced trials has improved or declined. This data will be a catalyst for the discussion.
  • How should we as an industry interpret and put into actions what is in the guidelines?
  • How are companies approaching risk management both from a pharm and CRO perspective?
  • Do they fill equipped to be able to deliver- skill set, tools and capabilities?
  • What is the dynamics between sponsor and CRO: How well do they work together?
  • How are people looking at risk when selecting vendors?
  • How do they ensure that they are working with oversight?
  • How do they regulate the oversight? What do they look for in audits?
  • How do you maximise the value and effectiveness of governance and achieving the balance of oversight between a sponsor and a CRO?


Other panel participants include:

  • Hayley Jewell, Regional Directory Clinical Operations, Eli Lilly, USA
  • Geoff Taylor, Director, Clinical Quality Assurance, Eisai Product Creation Systems, UK
  • Mr. Michael Zorer, Head of Clinical Operations, AOP Orphan Pharmaceuticals AG, Austria
  • Van Zyl Engelbrecht, Director, Clinical Research, UCC, UK
  • Melissa Bomben, Vice President, Global Alliance Management, Strategic Resourcing, INC Research/inVentiv Health, USA


View August 2017 Clinical Trials Innovation Article >>

View March 2018 Challenges of ICH E6 (R2) Article and Video >>



Want to speak with an Avoca representative about the event? Contact us today!