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Manageable Risk: Focusing on what Matters in Clinical Trials Seminar

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.

Please note a 10% discount is available for this seminar when booked with a two-day or full 3rd European QA Conference delegate package.  To take advantage of this discount, please add ALL items to your basket and enter PRECON in the discount code box.  
This seminar may also be booked as a stand-alone course.

 

Seminar Tutors

Tutors will be comprised from the list below:

Cathy Dove
Owner, Dove Quality Solutions (Course Principal)

Rosemarie Corrigan
Chief Quality Officer, Nordic Nanovector

Patricia Henley
Quality and Governance Manager, LSHTM

Robrecht Tistaert
Senior Director Global Quality and Compliance, PPD

Seminar Programme

Please note timings are subject to alteration

 8.45 Registration 
 9.00  Welcome
 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
 10.30 Break 
 10.45 Tools and techniques for capturing, assessing and managing risk 
 11.30 Workshop introduction 
 11.40 Workshop - Protocol Risk; identification, assessment and capture 
 12.30 Lunch 
 13.15  Workshop feedback
 13.45 CRASH 2 How did it end 
 14.00 Auditing Risk Based Monitoring studies 
 14.45 Risk based audit programmes 
15.30 Break 
 15.45 Development of Quality Tolerance Limits (QTLs) 
 16.30 Summary and discussions 
   

 

Seminar Material

Following requests from attendees of previous RQA events we are pleased to offer delegate material in PDF format for delegates attending this seminar. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post seminar
  • Environmental benefits – less paper being used per 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.

 

Accommodation (not included in seminar fees)

Please see here for an accommodation link.

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