Update in Clinical Research & GCP

Update in Clinical Research & GCP        

Keep your knowledge updated! 

Recording of a virtual update course on Tuesday April 13, 2021, 2 pm to 3.30 pm BST, 3 pm to 4.30 pm CET, 9am-10.30am EDT (Boston).

This webinar presented short summaries and key information relating to a number of recent developments and information. It was a mix of presentations, poll questions and discussion.

Introductions

·         Overview of the latest inspection findings and key points of focus.

·         Remote inspections – advice from inspectors.

·         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.

·         Are you ready for the period post pandemic? … the inspectors will be!

·         Update on the EU Clinical Trial Regulation – current status, CTIS progress and associated guidelines

·         Dealing with non-compliance – have you identified the risks and making sure your CAPAs are not ‘wishy washy’.

·         Now that UK has left the EU … new requirements and data protection.

·         Hot news items

Participant question time

 

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