Jolien Baele

Jolien Baele

Clinical Study Associate Galapagos

Conference Day Two

9:00 AM CASE STUDY: IMPLEMENTING TMF RISK-BASED QUALITY REVIEW FOR SPONSORS AND VENDORS

How the biotech Galapagos have looked at risk-based quality review when regarding all components of a TMF, collaborating with vendors and aiming for adequate quality at all times.

-        Identifying study specific critical data and processes to define scope and timing of TMF Quality review

-        Adapting strategy based on vendor collaboration, changing risks and QR findings

-        Including all stakeholders in the QR process

Check out the incredible speaker line-up to see who will be joining Jolien.

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Pharma IQ

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