Preparing for ICH E6 (R3) Good Clinical Practice Changes

How Risk Management and Quality Tolerance Limits (QTLs) Streamline the Process

Our industry is eager to learn what changes are included in ICH E6 (R3) Good Clinical Practice recommendations this year. Understanding how taking a risk-based, fit-for-purpose approach in the use of technology to conduct clinical trials will impact the industry’s current procedures. A key focus includes Quality Tolerance Limits (QTLs) and how clinical trial teams can identify, manage, and report risks associated with critical to quality factors that answer key questions and support sound decision-making while protecting patients. The focus of this webinar is how sponsors, CROs and sites can focus on quality factors at the time of trial design and prepare for these new rules.

Register for this webinar to learn about:

• ICH E6 (R3) changes and how they affect your clinical trials
• Current implementation roadblocks and methods to increase the adoption of QTLs in clinical trials
• How to identify Critical to Quality (CtQ) factors and use them to create focused indicators of quality
• How to prepare your clinical development for upcoming compliance requirements

Speakers

Brian Barnes, Senior Director, Product Development, Medidata

Brian Barnes is a Senior Director, Product Development – RBQM for Medidata Solutions. Brian has 15 years in the clinical development space and specifically supported RBQM for the past 9 years specializing in operational solutions for small to large pharma, biopharma and biotech companies. Brian is a co-liaison within the Associate of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on the topic of RBQM within a number of industry meetings, conferences and journals.

Message Presenter

Fiona Maini, BSc MSc, Principal, Global Compliance and Strategy, Medidata

Fiona’s role includes the evaluation of good clinical practice regulatory relevant changes impacting stakeholders managing clinical trials, with a key focus on regulatory aspects of technological advancements and geo-political dynamics. Specifically, impact of the EU Clinical Trial Regulation, ICH GCP revisions, impact of Brexit on the clinical trial ecosystem, advances in global data standardisation, use of robotics, artificial intelligence and regulatory adoption of mobile health applications within clinical trials. Most recently Fiona has been leading a global project interfacing with regulatory authorities with respect to the regulatory aspects of emerging patient centric technologies.  Prior to Medidata Fiona was a Director at Deloitte leading the Global Centre for Regulatory Excellence in Life Sciences, Regulatory Brexit Advisory Lead for Life Sciences and a Director overseeing Deloitte consulting services to the European Medicines Agency. Fiona has a MSc in Chemistry and BSc in Chemistry and Management Science.

Message Presenter

Josh Rochotte, Product Manager, Digital Oversight, Medidata

Josh Rochotte is Product Manager, Digital Oversight, responsible for the Medidata Virtual Monitoring and Central Monitoring Roadmaps. Josh also supports the development of Medidata Detect’s data science algorithms. He has been at Medidata for 4 years. Previously at Medidata, Josh was a Product Owner for the Data Viewer and RBQM Configuration Manager applications and an Implementation Consultant supporting midmarket enablement and implementation efforts in Professional Services. Josh holds a Masters of Information in Data Science and Information Management from Rutgers University and is an Advanced Certified Scrum Product Owner.

Message Presenter