Partnerships in Clinical Trials EU
November 28-29, 2017RAI Exhibition and Convention Centre, Amsterdam |
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MODERATOR: PATRICIA LEUCHTEN, CEO, THE AVOCA GROUPSTREAM 4: Governance, Oversight and QualityTuesday, 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!