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Monday, June 27 • 8:30am - 9:30am
#117: IDMP: A Compliance Project or a New Way of Conducting Business?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA



Chair
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.

Speakers
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry of NJ and a patent introducing a new anticoagulant. Debbie is excited about how big data is advancing personalized medicine and enjoys helping companies get their... Read More →


Monday June 27, 2016 8:30am - 9:30am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA