FDA Regulations and the updated ICH E6R2 addendum note more expansive requirements for vendor oversight including quality systems and risk management awareness. This does not mean after signing the contract, your team finds out they are not compatible with the vendor or the vendor cannot provide the full services needed for the study. The sponsor needs to have internal analyses and planning processes up front to define requirements for choosing the right vendor.
Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach. Sponsors are now even more responsible for vendor oversight and performance, but how is this accomplished?
- What do the Regulations mean?
- What’s new with the ICH E6 R2 Addendum
- Vendor oversight – Where do you start?
- Vendor management as a team approach
- Defining requirements
- Quality insight and input
- Pre-Qualification of a vendor
- Use of Tools and Processes
- Managing vendor performance
Who Should Attend:
- Contract VPs
- Quality VPs
- Clinical VPs
- Contract Personnel
- Clinical Managers
- Quality Managers