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Monday, June 27 • 10:45am - 12:00pm
#131: IDMP Update

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC



Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his BS from the University of Maryland.

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more recently the implementation and impact assessment of ISO IDMP.
avatar for Tom Macfarlane

Tom Macfarlane

Director, EU Regulatory Affairs Lead, Accenture
A Neuroscientist by training, Tom has since worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also advises on corporate operating models, technology, and the changes we face as a result of regulatory pressure, squeezed resources, and a rapidly coalescing healthcare system. Tom’s an HL7... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA