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Sunday, June 24 • 8:30am - 12:00pm
#21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

The Identification of Medicinal Products (IDMP) is a new industry regulation that pharmaceutical, biologics, and generic companies must comply with in the EU. The main objective of IDMP is to provide the basis for a unique identification of medicinal products. EMA is the first competent authority that has mandated the implementation of IDMP, and other regions (including the US and Japan) are expected to provide their deadlines in the near future. IDMP presents as an enormous challenge for companies to develop data governance standards on medicinal product data, identify sources of product data, harvest data efficiently and curate, review, and submit data to the EMA. During this short course we will present an overview of the current status of IDMP looking at regional implementation plans and timelines and we will look at some of the key challenges associated with IDMP for pharma – including data governance, data sourcing, data collection, and review. In response to some of the data challenges, we will examine various solutions and operating models for addressing IDMP and pay special focus on how IDMP will interface with pharmacovigilance — considering what data the pharmacovigilance department will typically need to provide to support IDMP and the data that the pharmacovigilance department is likely to consume. An additional registration fee is required for all preconference short courses.   Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for professionals in pharmacovigilance and regulatory affairs professionals.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Analyze the current status of IDMP
  • Identify the various solutions being developed to address IDMP requirements
  • Recognize how the IDMP impacts pharmacovigilance operations



Speakers
avatar for Jens-Olaf Vanggaard

Jens-Olaf Vanggaard

Director, HighPoint
Mr. Vanggaard is a strong team player and a results-driven senior Life Sciences R&D consultant with 9+ years of experience within Clinical Development and Regulatory Affairs implementing Clinical Data Warehouses, Meta Data Repositories, Clinical Trial Management Systems, Electronic... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 158 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA