Video from our recent CyntegrityEDU Webinar - ICH E.6(GCP) Addendum Quality Tolerance Limits Part 1. ICH E6 background (Structural & Non-structural) Quality Tolerance Limits (QTLs) Brief history of QTLs How to use the QTLs Potential benefits Part 2. Technology consideration of QTLs Considerations of enabling [...]
Four stages of RBM Evolution in a Pharma Company Intelligent software systems are facilitating the data accumulation in clinical trials already. The 75% of clinical trials are conducted with the Electronic Data Capture (EDC) [1]. The next step is to unfreeze the knowledge of [...]
How to avoid audit findings in a Risk-based Quality Management (RBQM) and risk management environment? What are auditors looking for?
The new Risk-based Monitoring concept reforms the clinical monitoring and clinical trial management. Risk factors become an important component there. What does it mean for a pharmaceutical company? Clinical trial risks are easy to foresee, site level risks and operational risks are hard to [...]
The article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting. [...]
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]
The WHO guideline on Good Data and Record Management practices is now final, below you find the link. Particularly interesting is that this guideline talks about quality risk management: Quality risk management and sound scientific principles. Robust decision making requires appropriate quality and risk management [...]
Pharmaceutical companies and contract research organizations (CROs) are increasingly trying to leverage technology to optimize risk-based monitoring. While technology is a critical component, roles also need to be looked at again. Recently we interviewed Dr. Nimita Limaye, an expert in risk-based monitoring, about the future [...]
ICH E.6 (R2) Scope of and need for Gap Analysis WEBINAR PROGRAM • ICH E.6 R2 History, Changes and Scope • Risk-based Quality Management • Quality Tolerance Limits • Risk-based Monitoring Plan • Examples • Gap Analysis • Electronic Media Validation • [...]
Click here for downloading the PDF version. Based on the source: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
