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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

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Session 6B: Reliable Data and Applied Technology

Session Chair(s)

Frits Stulp, MSc

Frits Stulp, MSc

Managing Director

Iperion Life Sciences Consultancy, 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

IRISS Forum, Spain

President

Armand Vermaire

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

Armand Vermaire

Qdossier B.V., Netherlands

Regulatory Operations Manager

David Sidney Ross, MBA, MSc, PMP, RAC

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

David Sidney Ross, MBA, MSc, PMP, RAC

AstraZeneca, United States

Senior Director, Regulatory Data and Submissions

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