ICH E2a, E8 & E9 (Live Online 24 Sep 2020)

Description
Regulatory

Every clinical researcher knows, or at least they should, ICH GCP E6 R2 needs to be followed for the conduct of any clinical trial. Even in the device research world, this guideline is used in tandem with ISO 14155. What most researchers are not sufficiently aware of is that this guideline should be read and applied in conjunction with other ICH guidelines relevant to the conduct of clinical trials, namely E2a, E3, E7, E8, E9 and E11 to ensure GCP compliance.

This TRIUM training is a first in a series of ICH guidelines training, starting with explaining the contents and relevance of ICH guidelines E2a (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E8 (general Considerations for Clinical Trials) and E9 (Statistical Principles for Clinical Trials) for the day-to-day conduct of a clinical trial. You will learn the safety reporting cycle from site to sponsor to regulatory bodies back to the site; including expedited reporting, the different development methodologies and trial phases and their rationale and the different types of trial designs, statistical principles and related relevant trial context, amongst others.  This training is intended to ensure proper understanding of your impact as researchers on the safety reporting and statistics, rather than a training on the execution of statistical analysis.

Real live examples and cases will be shared to ensure proper understanding and readiness for implementation immediately after.

TRIUM reference: T0350

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Explain the scope and general principles of the E2a, E8 and E9 guidelines
  • Describe the safety reporting cycle and related stakeholders and timelines
  • List the different phases of clinical development and related special considerations
  • Describe the relevant trial context and trial designs to ensure proper execution of the statistical principles
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”