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?
The learning objectives for this workshop include the following:
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.
Number of registrants per session: 3 per organization. Contact firstname.lastname@example.org for registering additional attendees for the course and the fee.
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.
This training workshop will be hosted on the Wool Training Institute, A Division of Wool Consulting Group's ZOOM Training Platform.
6 hour worskshop
3 hours March 21 & March 28, 2022
1 - 4 pm Eastern Time
Fee: $650 USD
Upon receipt of payment, a confirmation email will be sent with log-in information.