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Oliver Herrmann
This presentation will show you why it's so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.