Vendor Oversight: Ensuring Regulatory Compliance by Assessing Study Risks
Sponsored by Oracle Health Sciences
Tuesday, Nov. 17, 2020 | 1:00 p.m. EST | 10:00 a.m. PST
Location: Your office or conference room (no need to travel!)
ICH E6 (R2) introduces the concepts of vendor oversight and risk management, but have these requirements been implemented jointly or as separate initiative’s today? Is study risk also being taken into account in vendor oversight? The MHRA have stated, “Sponsor oversight is not just the initial vendor assessment process, it should be demonstrated throughout the trial. A risk-based approach to vendor selection and management is recommended…”
Fundamental to these new guidelines, and the forthcoming ICH E6 (R3), is the modernization of processes and technology to clinical trials with a focus on quality, and in particular Quality by Design, and risk-based management approaches that emphasize a proactive approach to tackling operational efficiencies and a movement away from an overreliance on retrospective practices.
Simply handing off clinical trials to CROs without initially quantifying study risk is hardly a wise move, yet what kind of oversight is needed? And more importantly, how can this be implemented end-to-end?
In this webcast we will explore:
- The intended purpose of ICH regulations to implement industry best-practices.
- How current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidance’s.
- How by implementing QbD in your operational processes you can ensure study risk assessment in your vendor oversight – end-to-end.
This webcast is applicable to:
- Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating trial metrics
- Sponsor and CRO roles responsible for project management of studies and operational excellence
Meet Your PresenterS:
Head of Business Operations
Novartis Institutes for BioMedical Research
Barry is a clinical trial and operations management expert. His experiences as an Oncology nurse, clinical trial coordinator and his senior management roles at Novartis, Roche, Merck, and AstraZeneca provides him with a well-rounded set of skills and experiences in the clinical trial space. His passion is transforming study management and trial execution processes through the creation of optimized business processes, which are supported by facilitating systems, which allow sponsor and investigator teams to meet their patient and clinical program goals faster and more efficiently.
Risk Based Approach Ltd
Andy is probably the worlds leading expert on the implementation of risk management and Quality by Design in clinical development and has provided consultancy in ICH E6 R2, ICH E8 to over 40 company’s/groups across five continents. Andy has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials.
Andy has forty-six years experience in the pharmaceutical industry and NHS, and was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications, include the paper with Dr. Alistair Ross on GP Audit. Throughout the 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.
Director, Industry Strategy
Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.