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Ottawa Marriott Hotel

2017年10月17日 (火) 午前 7:00 - 2017年10月18日 (水) 午後 3:00

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Session 4C: Identification of Medicinal Products (IDMP)- Updates and Implementation Approaches

Session Chair(s)

Maggie  Graham

Maggie Graham

Senior Policy Analyst, Natural and Non-Prescription Health Products Directorate, Health Canada, Canada

The ISO IDMP standard, and the European implementation of it, present a number of challenges in terms of the data that must be collected, managed, and submitted to the agencies. Explore how companies can – and should already be starting to – approach IDMP implmentation. Speakers will address how to design new processes for handling IDMP requirements and how to react to evolving requirements.

Speaker(s)

Donald  Palmer, MA

Donald Palmer, MA

Consultant, United States

Session Co-Chair

Joel  Finkle

Joel Finkle

Industry Expert, Retired, United States

IDMP: Incrememental Data, More Processes

Vikesh  Srivastava

Vikesh Srivastava

Associate Director, Business Informatics Division, HPFB, Health Canada, Canada

IDMP Overview and a Regulators Perspective

Brooke  Casselberry, MS, RAC

Brooke Casselberry, MS, RAC

Vice President, Advisory and Delivery, Epista Life Science, United States

Industry Perception and Action on IDMP Standards: US and EU

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