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

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Content current as of:

01/04/2023

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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