Protocol Risk Assessment Made Simple

This webinar is designed to help anyone developing protocol risk assessments under the new Quality Management section 5 of ICH E6 (R2).
Wed 27th September, 10.30am EST

Protocol Risk Assessment – limited attendance, please register quickly

Why is this webinar so important?

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.

 What will we cover?

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.

Why are we running it, and why is it free?

If you look back at our website, you will see that since we started TRI we have been committed to communicating and sharing our ideas and experience with our industry colleagues and customers. We find that the more we work for industry, the more the industry wants to work with us, and so everybody wins!

We all know people who are either in clinical trials, or using drugs developed as a result of clinical trials, and hence we all understand the importance of safety and quality.

The bottom line is – this is important, on many levels and the faster industry adopts these practices the better.

That’s our belief and so we’d like to prove it!

 

 

Who will be running the webinar?

The webinar will be run by Tammy Finnigan and Duncan Hall from TRI.

Tammy Finnigan, COO Triumph Research Intelligence

 

Duncan Hall, CEO Triumph Research Intelligence

 

Registration

Firstly, registration is limited to 100 people, so please do not register if you don’t plan to attend. We also suggest you register quickly!

Registration is open to anyone from Sponsor or CRO organisations, and selected business partners.