All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments to be conducted by the clinical trials sponsors and Clinical Research Organizations (CRO). However, conducting risk assessments and developing adequate Risk Management Plans (RMP) are not easy tasks, and not all the organizations conducting clinical trials have robust Quality Risk Management (QRM) programs.
In clinical trials we manage risks every day, this training covers a systematic approach on how to better do it according to ICH GCP E6 (R2).
The complexity of current global clinical trials requires of a more systematic approach to ensure the quality that patients, regulators and society expect for the treatments we deliver.
This training is oriented to professionals like you who manage risks in organizations, make decisions, set and achieve objectives and improve performance.
Training Goals and Course Content
Principles of Quality Risk Management
Quality Risk Management Program
Quality Risk Management Process
Clinical Quality Risk Management Overview
Critical Process and Data Identification
Quality Risk Management Tools and Methodologies
Save time when conducting risk assessment and provide clarity on the areas you need to focus on to guarantee a successful and stress free clinical trial.
Implement a clear process and receive a step by step guidance on how to conduct Quality Risk Management.
Understand Quality Risk Management principles (which are the key criteria for its success), goals, and how to achieve those goals in the Clinical Research setting.
Know how to identify, evaluate, prioritize and control risks and how to implement specific techniques for risk management according to ICH GCP E6 (R2).
Learn how the Quality Risk Management process can help companies to be more proactive and improve the quality in their clinical trials
Years of GCP Auditing and Clinical Quality Assurance experience have been incorporated into this course aiming to provide practical advice to professionals managing clinical trials based on expert interpretation of GCP and other applicable regulations, and industry best practices.
This course will help you to understand how QRM can improve the quality of your trial by guiding you through a powerful risk management process. We present risk management as a core element of an effective Quality Management System (QMS).
This training course reinforces the need to focus on errors that matters and not to treat every error equally to avoid unnecessary burden and overload resources. It clearly explains that potential issues should be identified before activities are undertaken and how to addresses them proactively.
You will discover how to identify those risks that matter associated with your clinical project, classify those risks, evaluate, and prioritize them.
Our focus is not only on summarizing the QRM key steps, but we also include explanations and examples of the key deliverables such as for example Risk Management Log, Risk Management Plan.
The components of a QRM program are broken down including foundational elements and QRM methods appropriate for clinical development.
This training course provides you with the basics for risk management processes that can be immediately applied to your clinical trials.
This GCP course is NOT for everyone, and we prefer to help you figure it out before you register rather than wasting your time and money
If your main goal is to attend a quick GCP course to obtain a GCP certificate but you are not interested in learning and improving your performance, this course is not for you
You can get a good feel for exactly what the content is and how much it offers with this video:
The course was designed and written by Dr Leire Zúñiga with the input from recognized clinical research professionals worldwide.
Dr Leire Zúñiga is the Founding Director and Principal GCP Consultant of Pharmity.
Leire has worked in the Pharmaceutical, Biotech and CRO industries since 2003 within Quality Assurance.
Just before moving to the consulting area and setting up Pharmity, Leire worked as a Senior Quality Assurance Manager in one of the largest CROs working as part of a global compliance team for internal and external clients worldwide.
During her professional career Leire has developed an in-depth knowledge in Quality Assurance, having conducted GxP and CSV audits across the globe.
The training course was recorded by one of the Pharmity’s native English speaker collaborators.
Quality Assurance Manager (Germany)
Easy to follow and assimilate while covering various and important aspects of risk management for clinical trials. The chapters were very well delivered with proper explanation of all the topics and lessons. Thumbs up!
Global Project Manager (UK)
I found the chapter on quality risk management process especially interesting; it pulled the course together. Overall, the content was excellent.
Clinical Operations Manager (US)
I’ve been trying to learn clinical quality risk management to increase my skills and this course was perfect! The video tutorials helped a lot. Great course!
So, you have questions? Let us try to answer those for you...
This is what you'll get: