Are the Intended Benefits of ICH Regulations Obscured by the Adoption Struggle?

Craig Morgan
Head of Marketing, Study Startup

ICH E6(R3) is coming at a time when organizations are struggling to adopt ICH E6(R2). But should organizations wait until these guidelines are ratified to realize the intended benefits?

Fundamental to these new guidelines is the modernization of processes and technology (e.g., machine learning) to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices.

Emphasis on quality is everywhere, but study startup is a hotspot, as it is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages which can derail a study resulting in costly rescue interventions, often due to issues that are preventable.

Please join us for this webcast:

Live: Tuesday, August 25, 2020

1pm EDT | 12pm CDT | 10am PDT

On Demand: available after airing until August 25, 2021

This webcast will explore:

  • The intended purpose of ICH regulations to implement industry best-practices and not to add additional burdens on clinical research staff.
  • How to realize proactive gains vs. incurred costs/compliance issues by adopting ICH regulations.
  • How by implementing QbD and risk-based management processes operational efficiencies can be gained by minimizing retrospective duplicate quality assurance steps.
  • How to enhance quality by minimizing protocol deviations/amendments by focusing on study design and startup.
  • Strategies to overcome adoption struggles and celebrate quick wins.

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


ANDY LAWTON, Consultant, 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.


CRISSY MACDONALD, Executive Director, The Avoca Group

As leader of Avoca's Integrated Consulting, Crissy provides consulting to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from preclinical research through late-stage clinical development.

Crissy earned a Ph.D. in biomedical engineering from Drexel University and a bachelor's degree from Lafayette College.

ELVIN THALUND, 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.

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