Overview of the content and impact of the new EMA and FDA guidance on computerised systems and electronic data in clinical trials.

A recording of the webinar originally run onThursday 15 June 2023, 1pm BST (UK), 2pm (CEST, Copenhagen), 8am EST (Boston).

Duration approximately 90 mins with additional time for questions.
Delivered by GCP and regulation specialists Prof Dr David Hutchinson and Dr Colin Wilsher, with expert data management input from Mr Mark Elsley.

This event is for anyone who undertakes clinical trials utilizing computerised systems, electronic clinical outcome assessments eCOA), interactive response technology (IRT), electronic case report forms (eCRFs), electronic informed consent, electronic signatures, artificial intelligence or uses clinical systems.

The EMA guideline replaces the important 2010 reflection paper on e-source data and comes into effect on 7 September 2023. Compliance will be critical to avoid findings during inspections.

This webinar will focus on the EMA guideline and its impact on the principles, key concepts and requirements relating to the use of computerised systems and electronic data collection in clinical trials.

The guideline raises some new requirements as well as reinforcing existing requirements. Where appropriate we will highlight the differences brought about by the FDA’s draft new Q&A guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations.

Don’t forget our range of online training and new electronic books – you will be amazed!