ICH E6 Addendum R2 Team Training and Action Planning

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ Leadership & Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

The revision (R2 Addendum) of ICH E6 Guidelines was in response to the increase in scale, complexity, and cost of clinical trials. The new revision focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation.  A foundational understanding of these topics is critical to running successful trials.  Therefore, it is important to train your team on the revisions and have an action plan to implement improvements with change control in mind.

This session will provide you and your colleagues training on the major updates and how they specifically impact clinical researchers. Within each section covered, the training includes use cases to support application of the new requirements and suggestions for action planning.

LEARNING OBJECTIVES

This 60-minute course will provide you with the essential information you need in regard to the changes in ICH GCP, and application strategies regarding the new responsibilities and best practices. By attending this interactive live session, you will be able to:

  1. Apply critical thinking techniques for effective implementation of the new ICH E6 guidelines
  2. Learn how the new guidances affect your role
  3. Discuss challenges and opportunities in implementing the new guidances

Who Should Attend

WHO SHOULD ATTEND

This course will be valuable to anyone working in clinical trials.  Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles.  This course will be of particular interest to those managing, leading or working in a training function.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

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