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Fairmont Rey Juan Carlos I

Nov 29, 2018 9:00 AM - Nov 30, 2018 6:00 PM

Av. Diagonal 661 – 671, 08028 Barcelona, Spain

eDM 2018 - Clinical and Regulatory Operational Excellence Forum

Electronic Data and Document Management – The Next Industrial Revolution

Session 6B: Reliable Data and Applied Technology

Session Chair(s)

Frits  Stulp, MSc

Frits Stulp, MSc

Chairman of the Board, CTADHL, Netherlands

Session 6B: Reliable Data and Applied Technology

Speaker(s)

Remco  Munnik

The use of SPOR/IDMP and the Impact on Regulatory Affairs and RIM Solutions in the EU

Remco Munnik

President, IRISS Forum, Spain

Armand  Vermaire

eCTDs for NPs, Baselines submissions and Validation issues for NP and MRP/DCP

Armand Vermaire

Regulatory Operations Manager, Qdossier B.V., Netherlands

David S Ross, MBA, PMP, RAC

Global Submission Management: RIM perspectives on planning, reporting and automation

David S Ross, MBA, PMP, RAC

Senior Director, Global Regulatory Policy and Intelligence, AstraZeneca, United States

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