This Solution Provider Webinar is brought to you by DIA in cooperation with Covance, Inc.
This complimentary archive is available for viewing through January 31, 2016.
Archive duration: 1 hour 29 minutes
The application of Risk-Based Monitoring (RBM) is a hot topic across the industry yet the final Agency guidance, released in August of 2013, has led to more questions within pharmaceutical companies and CROs on how to transition this newly revised guidance into processes for implementation.
Within this session we will examine regulatory (the visionaries’) and industry (the implementers’) viewpoints and how together we can explore practical approaches in translating the latest expectations in to real life clinical trial conduct. An emphasis will be placed on how to balance resources, quality of data and design, technology, risk awareness, different aspects surrounding the transformative impact to process, as well as barriers to RBM adoption.
Who should attend?
- Operations and Project Management
- Clinical Safety and Pharmacovigilance
- Therapeutic and Portfolio Heads
At the conclusion of this webinar, participants should be able to:
- Discuss the FDA’s Final Guidance on Risk-Based Monitoring and its purpose
- Discuss examples of approaches to translate regulatory expectations into actual clinical trial conduct
- Describe the different implementation strategies organizations may pursue with respect to RBM