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ABOUT THIS EVENT

Identification of Medicinal Products (IDMP) is a set of five standards developed by the International Organization for Standardization (ISO) (www.iso.org). Together, these five standards, along with their respective technical specifications, will make it possible to uniquely identify medicinal products globally and to standardize the electronic exchange of medicinal product data. FDA’s recent guidance on IDMP explains FDA’s position and progress on aligning the Agency’s standards to IDMP standards to identify and describe marketed medicinal products with the goal of harmonizing the standards for the international exchange of medicinal product data.

This webinar will provide an overview of the FDA Guidance on IDMP – Implementation and Use, along with a status update of the international activities focused on global implementation. The primary focus of the webinar is to discuss specific pharmacovigilance and drug shortage use cases that demonstrate the global benefits that IDMP standards will deliver.

INTENDED AUDIENCE

• Regulatory affairs professionals working on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions
• Consultants focused on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions
• IT professionals focused on the electronic exchange of medicinal product information
• International regulators and industry focused on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions

TOPICS COVERED

• Overview of the FDA Guidance on IDMP – Implementation and Use
• Status of the international projects focused on global implementation
• FDA will discuss specific pharmacovigilance and drug shortage use cases demonstrating the value-added impact that IDMP will deliver.

FDA SPEAKERS

Ron Fitzmartin, PhD, MBA
Sr. Informatics Advisor
Data Standards Branch (DSB)
Division of Informatics (DI)
Office of Regulatory Operations (ORO)
Center for Biologics Evaluation and Research (CBER) | FDA

Ta-Jen Chen
Sr. Project Management Officer
Data Standards Staff (DSS)
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA

Sonja Brajovic, MD
Medical Officer
Regulatory Science Staff (RSS)
Office of Surveillance and Epidemiology (OSE)
CDER | FDA

FDA RESOURCES

• Guidance Document - Identification of Medicinal Products — Implementation and Use
• GIDWG: getting IDMP done
• Identification of Medicinal Products (IDMP)
• International Organization for Standardization (ISO)
• Identification of Medicinal Products: Path to Global Implementation – 2021 SBIA Webinar

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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