RBQM Guide - The Clinical Researcher's Guide to Risk-based quality management

Risk-Based Quality Management (RBQM)

The Clinical Researcher’s Guide to RBQM

Risk-based quality management (RBQM) takes the principles of risk-based monitoring and applies them to the entirety of a clinical trial.

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Artem Andrianov & Johann Proeve

01 the book

About
The Book

Content

Introduction
Fundamentals of Risk and Quality Management
Regulatory Framework
Risk-Based Quality Management in Pharma Product Development
Quality by Design & Quality Management System
Quality risk management in a QMS
Risk-Based Quality Auditing and Inspections
Operational plan of rolling out of QbD and RBQM in a Pharma Organization
Cost Optimization Potential in Clinical Operations with RBQM approach
Risk Management in Clinical Trials
Handling Quality Issues and Deviations
Options for an RBQM organization
Future Trends and Challenges in Risk-Based Quality Management
Conclusion

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About
The Author

Dr. Artem Andrianov, Ph.D.

Artem Andrianov, Ph.D., is a highly accomplished and experienced professional in the field of clinical data quality and biostatistics. As the CEO of Cyntegrity, he brings over 25 years of expertise to the table, having worked on a wide range of projects in the pharmaceutical industry.

Artem Andrianov holds a Ph.D. in Mathematical Modelling and an Executive Master of Business Administration from Cass Business School. He is committed to pushing the boundaries of RBQM and driving it to new frontiers.

In 2013, Artem Andrianov co-founded Cyntegrity, a company specializing in data-driven risk management in clinical trials. He has been instrumental in the growth and success of the company and continues to lead the way in advancing the field of RBQM.

02 Author

About
The Author

Dr. Johann Proeve, Ph.D.

Johann Proeve has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former international role of VP Global Data Management at Bayer Healthcare.

Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, Johann Proeve is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, he has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM, PCT, PharmaForum, and SCOPE.

Johann Proeve holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).