Trial Master File and Inspection Readiness Conference

30 November - 2 December Sheraton Airport Hotel, Brussels, Belgium

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Martin Hausten

Head of Global Document Quality Center Boehringer Ingelheim

Conference Day One

10:50 AM CASE STUDY: MAINTAINING TMF AND SITE COLLABORATION AS ONE END TO END PROCESS

CASE STUDY: MAINTAINING TMF AND SITE COLLABORATION AS ONE END TO END PROCESS

Focusing on principles that when considered can form the foundations to build a more effective, functional and collaborative culture around TMFs, this session will detail key strategies and groundworks to ensure relationships with stakeholders are considered as an end-to-end process whilst given the support needed to ensure collaboration is maximised.

- Quality by Design – Benefit for TMF

- Understanding key steps in the TMF & Site Collaboration process

- From process design to SOP authoring

- Develop a TMF and Site Collaboration process faceplate

- How active TMF management can contribute to speed and value in Clinical Development

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

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