ICH E8(R1) Implementation Insights &Tips! Virtual Training

 ICH E8(R1) Guideline on General Considerations for Clinical Studies provides DIRECTION to sponsors, CRO-Vendors and sites the organizational REQUIREMENTs (infrastructure, procedures, processes, documentation, roles and responsibilities) that ICH E6 GCP does not address.  

This workshop uniquely provides the following for YOU that answers your needs and questions -how do I implement these requirements?

• Why ICH E8 (R1) establishes the 'framework' for implementation (e.g. risk-based quality management, clinical trial risk management, quality management)
• Overview of the 'Principles' - which means requirements
• Impact of each Principles requirement - clinical quality system, processes, procedures, job descriptions, Study Team RACI, qualified personnel attributes and study team training and development requirements
• Maps out, for each phase of the study, the requirements - for a holistic, overarching understanding of the requirements  - study concept, study design, study planning, study conduct , and study closure.
• Course materials - Participant Guide for Day 1 and Day 2
• This WILL NOT BE a boring workshop!

 The learning objectives for this workshop  include the following: 

• Describe the General Principles in ICH E8 (R1)  
• Discuss designing QUALTY into clinical trials    
• Identify clinical study design elements and data sources for clinical studies 
• Assess trial execution activities that includes study conduct, participant safety and study reporting  
• Interpret considerations in identifying critical to quality factors

In October 2021, ICH published FINAL ICH E 8 Guideline on General Considerations for Clinical Studies R(1) - this means YOUR organization needs to to evaluate, NOW, their practices and determine what they would need to do - to be in COMPLIANCE with the final ICH E8 (R1).    Remember there  is NO grace period once the final document is published.

Come ready to participate with your colleagues, learn and confirm insights for effective implementation.  

• This is NOT a webinar - this course is filled with engagement with the trainer, answering your needs and question
• Come ready to participate with your colleagues, learn and confirm insights for effective implementation  
• WebCAMs are preferred to be 'ON' so that this 'feels like an in-person workshop' that  fosters learning, sharing and community - come to class 'CAMERA-READY'   

Requirements

• Download current ZOOM version onto computer

Number of registrants per session: 3 per organization. Contact liz@woolcg.com for registering additional attendees for the course and the fee.

Your Instructor

Join us for the course, with Liz Wool, RN, BSN, Fellow - ACRP, CCRA.   Liz is an international speaker and trainer for foundational and advanced clinical research topics to excellent reviews. Liz's passion and expertise emanates through the webcam to participants internationally.   Liz is a certified instructional designer (CID) and certified master trainer (CMT) thereby bringing virtual classroom training design, development, interactions and activities ALIVE during this workshop.   

Liz leads the advisory and consulting services for the Wool Consulting Group and the Wool Training Institute.  Liz has over 30 years of clinical research experience, and 23 years in education and training, and is a recognized subject matter expert (workforce development, operations, compliance, clinical research, effective and engaging virtual classroom training development and delivery), trainer, and international speaker with a focus on solutions and added value results for clients.   

Liz's expertise produces results in both organizational effectiveness and efficiencies (design, re-design, modifications for growing companies, and post-mergers and acquisitions) in support of the organization’s goals.   

Cancellation Policy: You Must Cancel 5 days before the first day of the workshop. Cancellations after this time provide a credit to a future course/workshop.