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International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP): Will Your Company Be Ready by 2016?
Session Chair(s)
Niels Gronning, MSc
Senior Specialist
Microsoft, Denmark
New regulations for the IDMP currently being finalized by the EMA and the FDA will fundamentally alter the way data is standardized and shared across the pharmaceutical industry. ISO IDMP and the associated implementation guidelines collectively define how data should be standardized across authorized products, investigational products and substances (drug substances and excipients). Set to be implemented in the EU by July 2016 and with no official implementation guidelines, available pharmaceutical companies struggle to devise strategies that support compliance and continuous maintenance. Will you wait until the official implementation guideline is published (thereby possibly not meeting the deadline) or will you use the draft implementation guideline published by ISO as a blueprint for your strategy? How can IDMP be transformed from yet another regulatory burden into a value adding activity that supports enterprise architecture activities across your company?
Learning Objective : Describe the ISO identification of medicinal products (IDMP) standard; Discuss the myriad of challenges posed by these standard including the expected legislative requirements; Describe this standard in terms of business benefits and corporate strategies that collectively may impact pharmaceutical companies across business areas; Discuss how other pharmaceutical companies deal with IDMP compliance.
Speaker(s)
Coming Into Compliance with IDMP
Lior Keet, MBA
HighPoint Solutions, United States
Vice President, Life Sciences R&D
IDMP: Industry Versus Regulator Point of View
Greg Brolund, MS
Chicopee Falls Consulting, United States
Consultant
Enterprise Architecture and ISO IDMP: A Match Made in Heaven?
Niels Gronning, MSc
Microsoft, Denmark
Senior Specialist
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