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Fairmont Rey Juan Carlos I

2018 年 11 月 29 日 9:00 上午 - 2018 年 11 月 30 日 6:00 下午

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

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  Ross, MBA, MSC, PMP, RAC

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

David Ross, MBA, MSC, PMP, RAC

AstraZeneca, United States

Senior Director, Digitial Advocacy and Policy

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