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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 2: Global IDMP Implementation – Getting Closer to the Goal

Session Chair(s)

Nimesh  Patel

Nimesh Patel

Senior Director of Global Regulatory Systems , Eisai Co., Ltd., United States

The Identification of Medicinal Products (IDMP) offers a global framework for unique identification and consistent documentation of medicinal products, facilitating information exchange among regulators, manufacturers, suppliers, and distributors.

This session will present an overview of the testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The model's readiness for deployment, including its software functionality, interoperability, processes, and business rules will be discussed.

Malin Fladvad, Uppsala Monitoring Centre

Isabel Chicharo, European Medicines Agency

Flávia Moreira Cruz, ANVISA

Philipp Weyermann, Swissmedic

Vada Perkins, Boehringer Ingelheim

Karin Hay, Health Canada

Learning Objective :
  • Describe the significance of IDMP
  • Identify the current state of IDMP implementation
  • Evaluate the challenges and benefits of IDMP adoption
  • Assess the readiness of regulatory bodies for IDMP
  • Discuss global collaboration on IDMP implementation
  • Explore practical implications of IDMP for industry

Speaker(s)

Isabel  Chicharo, MPHARM

Isabel Chicharo, MPHARM

Head of Regulatory Data Management, European Medicines Agency, Netherlands

Speaker

Philipp  Weyermann, DRSC, MSC

Philipp Weyermann, DRSC, MSC

Head of Unit Regulatory Assessment 2, Swissmedic, Switzerland

Speaker

Karin  Hay

Karin Hay

Senior Policy Analyst, Health Canada, Canada

Speaker

Flávia  Moreira Cruz, PHARMD

Flávia Moreira Cruz, PHARMD

Specialist at Pharmacovigilance Officer (GFARM), ANVISA, Brazil

Speaker

Malin  Fladvad, PHD, MSC

Malin Fladvad, PHD, MSC

Portfolio Officer, Uppsala Monitoring Centre, Sweden

Speaker

Vada  Perkins, MS

Vada Perkins, MS

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Speaker

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