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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

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

Speaker

Isabel Chicharo, MPharm

European Medicines Agency, Netherlands

Head of Regulatory Data Management

Philipp  Weyermann, DrSc, MSc

Speaker

Philipp Weyermann, DrSc, MSc

Swissmedic, Switzerland

Head of Unit Regulatory Assessment 2

Karin  Hay

Speaker

Karin Hay

Health Canada, Canada

Senior Policy Analyst

Flávia  Moreira Cruz, PharmD

Speaker

Flávia Moreira Cruz, PharmD

ANVISA, Brazil

Specialist at Pharmacovigilance Officer (GFARM)

Malin  Fladvad, PhD, MSc

Speaker

Malin Fladvad, PhD, MSc

Uppsala Monitoring Centre, Sweden

Portfolio Officer

Vada  Perkins, DrSc, MSc

Speaker

Vada Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

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