Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials (GCP Training)/ Leadership & Training/ Medical Device Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 60-Minutes
On-Demand
Includes handouts!

Description

COURSE DESCRIPTION

OVERVIEW

Yes, change is coming again.

A new ICH E6 Good Clinical Practice (GCP) revision linked to the revised ICH E8 (R1) Guideline “General Considerations for Clinical Trials” is due to be finalized soon. These changes are coming during (or soon after) the COVID-19 pandemic which hugely tested GCP systems, revealing that many are not well equipped to adapt to risk. The adoption of a risk-based approach and quality by design has been slow. The 2016 ICH E6 R2 revision was a good global start to harmonizing and modernizing clinical trials but it lacked a clear connection to ICH E8, specifically to better support the link between study design and study conduct. That change is here.

Expected updates to ICH GCP and ICH E8 support the agility and adaptability we need to reach the levels of study design, management and conduct closest to the data and study participants. Taking these theoretical concepts into flexible and reliable and accountable practices is the next step in more effective trials.

Join us for this 60 minute session where you will learn where these guidances are headed…and what you can do immediately to prepare. Specifically, this webinar will outline the biggest internal barriers related to mindset and quality systems – which will be key points of the revisions. As many firms did not properly prepare for change before ICH E6 R2, it created a slow and costly process to assimilate meaningful change. Therefore, preparation for these new changes is essential.

Come to this webinar to discuss:

  • What is likely to change from ICH GCP E6 R2
  • Why ICH E8 also is also changing
  • What are some additional themes and reasons for change that you should know (i.e., “critical-to-quality factors” and related gaps in critical thinking)
  • Steps you can take as a site, sponsor, or CRO to assess gaps in essential mindsets, skill sets, and systems to prepare for these changes
LEARNING OBJECTIVES

At the completion of this session, you will be able to:

  • Apply critical thinking to understanding the scope of expected updates to the ICH guidelines
  • Recognize how the new guidelines may affect your role in GCP
  • Discuss challenges and opportunities in planning for changes

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a clinical trials environment on global or domestic scale. This includes…

  • Clinical Operations
  • CRAs
  • Sites/Sponsors/CROs
  • Clinical Quality
  • All related functions

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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