Regulatory Submissions, Information, and Document Management Forum

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Session 9: Track 1: Preparing Regulatory Affairs for the Use of SPOR/IDMP and the Benefits it can Bring

Session Chair(s)

Sarah Powell, RAC

President

Powell Regulatory Services, United States

This session will review the current status of IDMP implementation in the EU and the impact of SPOR on regulatory teams today, and in the future. The session will also review how effective data information management can provide benefits beyond compliance with regulations.

Learning Objective : At the conclusion of this session, participants should be able to:
Explain the SPOR implementation in Europe and the impact on daily activities performed by regulatory staff
Apply practical recommendations to current processes and systems to prepare the organization for SPOR requirements in the EU
Describe the benefits of IDMP to the business beyond compliance

Speaker(s)

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

Remco Munnik

IRISS Forum, Spain

President

Preparing for SPOR in Europe: What Are the Latest Developments in the EU Implementation of IDMP and What can You do Now?

Kelly Hnat

K2 Consulting/Gens & Associates, United States

Principal

Turning IDMP into an Data and Information Management Project with Benefits Outside of Compliance

Andrea Herrmann, PharmD

Merck Healthcare KGaa, Germany

Head of Regulatory Compliance & Regulatory Information Management