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Monday June 16, 2025 11:00am - 12:00pm EDT
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-519-L04-P; CME 1.00; RN 1.00

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

Chair

Janis Bernat, MSc

Speaker

Introduction of Regulatory Levers to Address the Problem: Global Implementation of Identification of Medicinal Products Standards
Ron Fitzmartin, PhD, MBA

Panelist
Vada Perkins, DrSc, MSc

EMA Perspective
Isabel Chicharo, MPharm

ANVISA Perspective
Raphael Sanches Pereira, SR

HealthCare Professional Perspective on the Issue and Examples
Joseph Kannarkat, MD

Panelist
Peter Hjelmstrom, MD, PhD


Speakers
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Isabel Chicharo

Isabel Chicharo

Head of Regulatory Data Management, European Medicines Agency, Netherlands
I am responsible for Regulatory Master Data Management Services, currently on Substances, Products, Organisations and Referential data (also known as SPOR). I also coordinate the implementation of ISO IDMP in EU. I over 20 years of data management experience in the field of Medicines... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is a Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provides policy and strategy consultation on electronic regulatory submissions and standardized data. Ron serves as Rapporteur for... Read More →
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre, Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
avatar for Joseph Kannarkat

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States
Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →
avatar for Raphael Sanches Pereira

Raphael Sanches Pereira

General Manager of the Office for Medicines, ANVISA, Brazil
General Manager of the Office of Medicines, responsible for evaluations off small molecules registrations and post-approval changes requests. Previously manager of Office for Quality Evaluation for Registration of Small Molecules and Manager of Office for Quality Evaluation of Small... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   14: DIAmond, Forum

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