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
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