Subject : The implementation of the Risk Based Monitoring as suggested by the draft guidance documents from FDA and EMEA and the (potential) role of Data Management in establishing, validating and supporting an Integrated Quality Risk Management plan.
Date and Time : Thursday, March 28th 2013 – 13:00 CET
Facilitated by : Christine Schneider Heyer, Boehringer-Ingelheim France
Open to : Everyone interested in the subject
About this topic:
Risk management principles have been effectively and efficiently used in most areas of business and government. This has been so every time where it is impossible to ensure the quality of a large volume of services or products by exhaustingly checking every single one of them but quality risk management has been rather limited in regulated clinical research, in particular in the area of Good Clinical Practice.
Until recently, Research and Development operatives (as well as their representatives / CROs) could afford to be so risk averse as to engage in full visual verification of all records and reports obtained in the context of human (Phase I-IV) clinical research.
However not only have exhaustive manual verifications shown their limits because of major direct cost increase of pharmaceutical R&D in the last 2 decades but also because they often miss to identify in a timely manner:
- fraud and misconduct
- safety related signals and trends across large datasets
- lack of safety, efficacy endpoint data quality as identified because of unacceptable intra- and inter-rater variability
The almost concurrent release last year of draft guidance documents from Regulatory Agencies on both sides of the Atlantic has triggered numerous discussions among clinical research operatives, peers and stakeholders and led to a variety of different risk based practices.
Data Management is being recognized as an important and indivisible aspect of centralized monitoring. Our role contribution in establishing, validating and supporting an Integrated Quality Risk Management plan will be discussed in the webinar.
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Lynn White, Functional Excellence Leader from Roche Products and the project lead for FFPM (Fit for Purpose Monitoring) as well as representatives of other companies will briefly present their current Risk Based Monitoring Approach to provide the basis for the discussion in whichthe following questions will be explored:
- What are the different approaches that companies are taking in response to the regulatory guidance?
- What is the current role of Data Management in these approaches?
- What should be the (future) role of Data Management in these processes?
- What are the challenges of implementing a risk based monitoring approach for data management?
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Registration : In order to register, please fill in the attached registration form and send it to the DMB secretary Carine JAVIERRE
Mail address : carine.javierre.dmb@gmail.com
Registration end : March 22nd, 2013 at 12:00 CET!
