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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)!

Advanced Rates Expire

DAYS

HOURS

MINUTES

SECONDS

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

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, 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.

Speaker(s)

Ron  Fitzmartin, PhD, MBA

Speaker

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Malin  Fladvad, PhD, MSc

Speaker

Malin Fladvad, PhD, MSc

Uppsala Monitoring Centre, Sweden

Portfolio Officer

Isabel  Chicharo, MS

Speaker

Isabel Chicharo, MS

European Medicines Agency, Netherlands

Head of Regulatory Data Management

Representative Invited

Speaker

Representative Invited

ANVISA, Brazil

Philipp  Weyermann, DrSc, MSc

Speaker

Philipp Weyermann, DrSc, MSc

Swissmedic, Switzerland

Head of Unit Regulatory Assessment 2

Vada A. Perkins, DrSc, MSc

Speaker

Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

Representative Invited

Speaker

Representative Invited

Health Canada, Canada

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