Webinar:
"Oops – we have a problem!" Part 1:
Identification, Escalation, Impact / Serious Breach assessment, immediate actions
Issues , deviations , non-compliance management.
Identification, Escalation, Impact / Serious Breach assessment, immediate actions
Issues , deviations , non-compliance management.
June, 18 | Wednesday
18:00 CET | 90 mins
Participation is free
We are pleased to announce the first part of our two-part webinar series.
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What will you get:
The attendees will get better clarity about what is coming with the E6(R3) in terms of deviations / issues / non-compliances management
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For whom:
Clinical research professionals working in / with the countries where the ICH GCP E6(R3) will be launched soon, or who are otherwise interested getting the information about the E6(R3) changes in issues / deviations / non-compliance management (including Serious Breaches, Root Cause Analysis, CAPA)
Key elements:
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A problem occurred in a clinical trial – what’s next? -
Is any deviation (from GCP, SOP or study protocol) awful or even worse? -
Important Protocol Deviations (IPDs) vs. Serious Breaches (SBs) – what is the difference and how to handle both of them in the E6(R3) realities?
Speaker
- Oleg ShevaldyshevMD, MRQA, MCC Champion
Quality and Training Director at The QARP- Independent Clinical Research QA Consultant, globally
- 22 years of GCP experience, including 13 years in QA
- Non-compliance and serious breach management
- Issues / risk management
- Process improvement / QMS management
- ISO certificates (9001:2015, 10002:2014, 19011:2018, 31000:2018)
- Publications in RQA Quasar
- MCC Champion award for contributions around CAPA and Risk management
What You’ll Learn
- This session will provide an overview of the updates concerning deviation/issue/noncompliance management in clinical trials, based on the recently published ICH GCP E6(R3) guideline, which is set to be implemented in the near future.
- Risk proportionality and impact assessment,
- Important Protocol Deviation (IPD) – an old concept now reaching the GCP,
- Serious Breaches – have they finally sneaked into the GCP?
- Actions – do them but do not overkill.