The identification and management of risk in Clinical Trials is an area of ever increasing focus. The implementation of ICH GCP (R2) including a whole new section dedicated to quality and risk management, along with the new Clinical Trial Regulation 536/2014 advocating a risk managed approach, leaves many of us wondering “What does this really means for us?”. “What should we be focusing on?”.
This interactive seminar will share real life experiences and examples of what works. One size does not fit all and this is your opportunity to access ideas and approaches to Clinical Trial risk management. Participants will get practical solutions and tools to enable support of their organisations in identifying, managing, mitigating and ultimately reducing the risks associated with clinical trials.
Tutors will be comprised from the list below:
Owner, Dove Quality Solutions (Course Principal)
Chief Quality Officer, Nordic Nanovector
Quality and Governance Manager, LSHTM
Senior Director Global Quality and Compliance, PPD
Please note timings are subject to alteration
|9.05||Overview of risk and quality management literature and guidance; ICH, ISO, EMA, FDA, Transcelerate, Clinical Trials Transformation Initiative (CTTI)|
|9.25||Pragmatic approach to risk in the non-commercial environment|
|9.55||Risk identification in the commercial environment|
|10.45||Tools and techniques for capturing, assessing and managing risk|
|11.40||Workshop - Protocol Risk; identification, assessment and capture|
|13.45||CRASH 2 How did it end|
|14.00||Auditing Risk Based Monitoring studies|
|14.45||Risk based audit programmes|
|15.45||Development of Quality Tolerance Limits (QTLs)|
|16.30||Summary and discussions|
Following requests from attendees of previous RQA events we are pleased to offer delegate material in PDF format for delegates attending this seminar.
The material will be emailed in advance of the seminar and RQA will not be providing any printed copies of the seminar notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
Please see here for an accommodation link.