We are pleased to announce that registration is now open for the virtual QRCC seminar titled “Sponsor Oversight of Outsourced Clinical Trials”. This seminar (a virtual version of the in-person Sponsor Oversight seminar held last year), will focus on the Sponsor oversight responsibilities as set out in the draft of ICH E6 R3 (the first time specific wording related to Sponsor oversight and delegation of responsibilities has been included in the ICH guidelines).  We will cover topics including:

  • The Quality Management Systems a Sponsor needs to ensure oversight activities are managed effectively and documented appropriately.
  • Selecting, managing and overseeing the CRO/3rd party vendor teams contracted to deliver a clinical trial.
  • Sponsor oversight documentation – how to file/what to file?
  • Ensuring the quality and completeness of outsourced Trial Master Files.

The virtual seminar will be held 30th April 2024 and is aimed at all those professionals who are responsible for the oversight of clinical trials outsourced to CROs/3rd party vendors. All the details are summarised here QRCC Seminar Series Flyer Apr 2024. To register and reserve your place, or if you have any queries relating to this event, please e-mail: enquiries@qrcc.co.uk or telephone 01480 309349. We look forward to seeing you on 30 April 2024!