We are pleased to announce that registration is now open for the first QRCC seminar since COVID-19, titled “Sponsor Oversight of Outsourced Clinical Trials”.
This seminar 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 in-person seminar will also provide an opportunity to network and discuss challenges and issues with colleagues and to hear about challenges and best-practices from a clinical trial Sponsor.
The seminar will be held at our premises in St Ives, Cambridgeshire on 30th November 2023 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 20231017 QRCC Seminar Series Flyer Nov 2023.
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 the 30th November!