Virtual | Virtual

Event Title

Global IDMP Implementation - Getting Closer to the Goal

October 16, 2024

Date:: October 16, 2024
Time:: 1:00 PM - 2:30 PM ET

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ABOUT THIS EVENT (Hosted by CDER SBIA)

Identification of Medicinal Products (IDMP) offers a global framework for the unique identification and consistent documentation of medicinal products, facilitating effective information exchange among regulators, manufacturers, suppliers, and distributors. Once fully adopted, these standards will enhance pharmacovigilance, address drug shortages, and improve medication safety worldwide.

This webinar will present an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The session will detail the model's readiness for deployment, including its software functionality, interoperability, processes, and business rules. Additionally, results from simulated real-world scenarios across three global IDMP use cases—Pharmacovigilance, Drug Shortages, and Cross-border Healthcare—will be discussed.

INTENDED AUDIENCE

Regulatory affairs professionals, international regulators and industry working on data standards, pharmacovigilance, product labelling, drug shortages, and electronic regulatory submissions
Consultants focused on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions
IT professionals involved with the electronic exchange of medicinal product information

TOPICS

Introduction to IDMP Standards:
- Overview of IDMP framework and its objectives
- Importance of unique identification and consistent documentation for medicinal products
Global PhPID Service Operating Model:
- Overview of the end-to-end testing project
- Generation of global PhPIDs for marketed medicinal products
- Readiness for deployment: software functionality, interoperability, processes, and business rules
Real-World Scenarios and Use Cases:
- Results from simulated scenarios for:
  - Pharmacovigilance: Enhancing drug safety monitoring
  - Drug Shortages: Addressing supply chain challenges
  - Cross-border Healthcare: Facilitating international healthcare

FDA SPEAKERS

Ron Fitzmartin, PhD, MBA
Sr. Advisor
Data Standards Branch
Office of Regulatory Operations
Center for Biologics Evaluation and Research

Ta-Jen Chen
Project Management Officer
Office of Strategic Programs
Center for Drug Evaluation and Research

OTHER SPEAKERS

Olof Lagerlund, PhD
Substance Expert
Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring

FDA RESOURCES

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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