Clinical Research and GCP Update

“Clinical Research & GCP Update” April 13, 2021 A 90 min virtual course delivered online 2pm BST, 3 pm CEST, 9am EDT

Please log in 10 to 15 mins before the start time to ensure that you have connection and sound. If you are unable to hear the webinar when it starts check that you do not have a pop-up box on your desktop that requires attention. If you still have problems email johu@brookwood-global.com This webinar will present short summaries and key information relating to a number of recent developments and information. It will be a mix of presentations, poll questions and discussion. Our pledge: if necessary, we will extend the session to ensure that all of your questions are answered. Introductions • Overview of the latest inspection findings and key points of focus. • Remote inspections – advice from inspectors. • Are you ready for the period post pandemic? … the inspectors will be! • How ICH E8 (R1) will affect clinical trial conduct. • How will you involve patients in your clinical trial development? – new MHRA requirement • ICH GCP renovation: the process, progress and what we can expect. • Dealing with non-compliance – have you identified the risks and making sure your CAPAs are not ‘wishy washy’. • Update on the EU Clinical Trial Regulation – current status, CTIS progress and associated guidelines Participant question time Bonus session – if you wish and your time allows you may stay on for this extension to the webinar. • Now that UK has left the EU … new requirements and data protection. • Hot news items

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A course designed and undertaken by Brookwood Global © 2021 5 Studley Court Mews, Chobham, Surrey, GU24 8EB, UK Tel: +44-1483-811383; info@brookwood-global.com www.brookwood-global.com Dedicated to training and independent certification in clinical research and GCP