April 10, 9:00am – 11:30am ET
Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and yet it is something we find many companies struggle to get started with.
Getting it right can mean that all functions have access to a well structured, well defined approach to the identification of risks to quality and approaches to dealing with those risks and their causes. It allows us to achieve the following:
- Early mitigation of risks through early planning and trial design.
- Better usage of clinical trial data for proactive risk identification.
- Clear identification of quality thresholds.
- Clear definition of what to do when a threshold is breached and who is responsible.
- Guidance on root cause analysis.
- A clear entry point into the practice of risk-based monitoring (RBM).
- Enterprise wide learning and capability development.
Getting it wrong, or not doing it at all can mean important risks are missed, patient safety and data quality may be compromised, and a likely return to the old, inefficient approach of focusing on everything (i.e. focusing on nothing) where monitoring and data review are concerned.
The webinar has been designed to take the audience from a high level regulatory and psychological perspective on risk management, through a practical framework for performing risk assessment and management, followed by some specific case study examples.
- This web based training and certification event is an interactive practical workshop on conducting risk assessment, evaluation and implementing risk controls.
- The session will describe the regulatory context, from ICH E6 (R2), set out a comprehensive framework for implementing the regulatory guidance and provide direction on turning theory into practice with interactive exercises.
- The session will include a protocol synopsis and risk assessment worksheet to support the exercises, which will be sent out in advance of the training.
- All attendees will be sent a signed certificate of attendance for their training records.
Who Should Attend This Training?
- Anyone who is involved in the design and risk assessment clinical trial protocols
- Anyone who will be conducting protocol risk assessments
- Anyone who is involved in the creation of risk management plans
- Anyone who is responsible for ongoing risk assessment and risk management during the clinical trial lifecycle
- Anyone who wants to improve their understanding of ICH E6 (R2) and the processes of risk assessment and risk management contained within.
What Does it cost?
The course is just $199 per person. (Group discounts are available for groups of five or more – please contact us directly for pricing)
What does that include?
- The training protocol and risk assessment worksheet sent out prior to each course
- The 2 ½ hour web based training session
- A copy of the training materials
- A certificate of attendance, signed by the trainer
To Register, click here
Once you have registered you will be sent an invoice for the training to your email address. This can be paid for by credit card or PayPal.
Once we have received your payment you will receive your joining instructions and the pre-course materials.
Thank you – we look forward to meeting you at the course !