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      3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research in Toronto


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      September 19, 2019

      Thursday   1:00 PM - 4:00 PM

      Online event
      Toronto, Ontario LV52V5

      Performers:
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      EVENT DETAILS
      3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research

      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?

      Seminar Agenda:

      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:

      CEOs
      Contract VPs
      Quality VPs
      Clinical VPs
      Contract Personnel
      GXP
      Clinical Managers
      Quality Managers
      FDB3484

      Categories: Conferences & Tradeshows

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.