The War in Ukraine and Good Clinical Practice
The objective of this webinar is to examine the tenets and requirements of Good Clinical Practice (GCP) in the context of the war in Ukraine and its effects on clinical research in the country and the region. The webinar explores the Ukrainian GCP guidance as well as EU, FDA, WHO, and ICH international guidances. It asks the question ‘To what extent is GCP fit for purpose in addressing clinical trials in a wartime situation and what, if any, new considerations should be brought to the table.
In collaboration with Ukraine Clinical Research Support Initiative (UCRSI)
This Webinar will be one hour in length followed by 30 minutes of member discussion where we welcome our attendees to turn on their camera, unmute their microphones, and share their thoughts/ask questions. We hope you can join the conversation about this important topic.
Who should attend?
- Clinical Data Management
- Clinical Data Management/eClinical
- Clinical Research
- Good Clinical Practice
- Medical Communications
- Patient Engagement
- Regulatory Affairs
- Research & Development
- Quality Assurance, Control
- Strategic Planning
- Discuss how continuity of research and care have been delivered for patients and trial participants in Ukraine
- Summarize approaches used in Ukraine and the surrounding region to maintain Good Clinical Practice compliance
- Evaluate the proposed revisions to ICH E6 and what might be considered to allow application during times of war