Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

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All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.

Speakers

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  • Anna Dachs Soler, PhD
Wed, 14 May
1130 – 1200

Ensuring Compliance of Digital Systems at Clinical Sites

GAMP
Anna Dachs Soler, PhD, AMBIT-BST
This session provides practical guidance on ensuring compliance for digital systems at clinical sites, focusing on strategies aligned with EMA expectations and insights from the updated ISPE GAMP guide on eClinical systems. Attendees will learn essential aspects of regulatory requirements, effective implementation methods, and ongoing verification practices to maintain continuous compliance. The session highlights the benefits of digitalization, such as improved efficiency and data quality, while addressing common pitfalls and validation mistakes to avoid. It is designed to help decision-makers ensure compliance while enhancing the overall performance of clinical activities.
Anna Dachs Soler, PhD
Senior Compliance & Digital Transformation Manager in Life Sciences
AMBIT-BST

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.