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ABOUT THIS WEBINAR

In this webinar FDA subject matter experts and guest speaker will:

• Provide an overview of FDA’s regulatory approach to Identification of Medicinal Products (IDMP)
• Address the status of the planned ISO updates to several IDMP standards
• Discuss FDA’s international collaboration with WHO and other regulators focused on global implementation
• Present examples of use cases for IDMP for both drugs and biologics

TOPICS COVERED

• IDMP Overview
• Current challenges with the IDMP standards and mitigation solutions using pilot projects
• IDMP use cases for drugs and biologics
• Path to Global Implementation

INTENDED AUDIENCE

• Regulatory affairs professionals working on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions
• IT professionals focused on the electronic exchange of medicinal product information
• Healthcare professionals preparing and submitting Individual Case Safety Reports (ICSRs)
• International regulators and consultants focused on data standards, pharmacovigilance, product labelling, and electronic regulatory submissions

FDA SPEAKERS

Ron Fitzmartin, PhD, MBA
Sr. Informatics Advisor
Office of the Director
Center for Biologics Evaluation and Research (CBER) | FDA

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

Vada A. Perkins, MSc, MS
Executive Director, Regulatory Policy & Innovation
Bayer Pharmaceuticals

• European Federation Pharmaceutical Industries & Associations (EFPIA) European Regulatory Affairs and Operations (ERAO) Working Group
• Pharmaceutical Research and Manufacturing Association (PhRMA) IT Working Group
• ISO TC 215 WG 6 IDMP Co-chair
• ICH M2 EFPIA Topic Lead

FDA RESOURCES

• Identification of Medicinal Products (IDMP)
• International Organization for Standardization (ISO)
• Identification of Medicinal Products: Path to Global Implementation – Webinar - June 11, 2021

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.
• pre-approved by 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.
• pre-approved by 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.
• approved by 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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