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A Critical Review of Current Initiatives and Guidelines with Regard to Their Impact on Sponsors Approach to Quality

A Critical Review of Current Initiatives and Guidelines with Regard to Their Impact on Sponsors Approach to Quality


This webinar will cover the current and planned changes to GCP (ICH E6 R2 / R3) and associated guidance ICH E8 R1) with their impact on the clinical development environment. The available resources via TransCelerate and CTTI, will be examined together with these groups background and other activities.


  • Understand Quality by Design in clinical Development - ICH E8 R1 draft
  • Understand the role of Quality Tolerance Limits - ICH E6 R2.
  • Understand the general changes in ICH E8 R1
  • Impact of "understanding the data" and perfection is rarely achievable


All - beginner to advanced


Participants will learn how their peers are handling data collection in the pandemic environment, specifically, what their concerns are and the tactics they are using to manage it.


Andy Lawton, Consultant at Risk Based Approach Ltd
Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials. He is currently consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2, ICH E8, QMS/QbD and Risk Based Monitoring. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim were he also held positions of increasing responsibility during his 32 years with BI. Andy 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 is the paper with Dr. Alistair Ross on GP Audit - throughout 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.

Tim Breen, former Director of Clinical Research Informatics, Hoosier Cancer Research Network
Tim was the Director of Clinical Research Informatics for the Hoosier Cancer Research Network for over nine years and retired in 2019. He has been involved in clinical research for more than 20 years. His interests are in the quality of data and the development of methods to efficiently maintain quality data. He has been the Chair of the SCDM Webinar Committee since 2009.

Donna Gugger, Associate Director, Turning Point Therapeutics

Donna Gugger Is an Associate Director, Data Management at Turning Point Therapeutics. She has over 30+ years’ experience in Clinical Data Management managing teams, overseeing operations and services, driving strategic initiatives, developing process improvements, and delivering high quality data. Donna is an active member of the SCDM Webinar Committee for the past 10 years. Her interests include risk-based strategies, innovative processes, metric reporting and visualizations.


Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.

Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.

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