FDA subject matter experts will introduce the Identification of Medicinal Products (IDMP) initiative, scope, and benefits. They will also discuss FDA’s approach and challenges with the adoption of the five International Organization for Standardization (ISO) standards. The goals, objectives and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS) will also be covered.
1:00 p.m.– 2:30 p.m.
This on-demand webinar is FREE.
After this webinar, attendees will be able to:
- List the five IDMP standards
- Explain FDA’s approach to IDMP
- Describe the value of IDMP
- Explain the purpose of the G-SRS system
- Regulatory affairs / operations
- Safety specialists
- CMC scientists
- Labelling specialists
- Terminology specialists
Ron Fitzmartin, PhD, MBA
Sr. Project Manager
Review Management | Office of the Director
Center for Biologic Evaluation and Research (CBER) | FDA
Ta-Jen (TJ) Chen, MS
Project Management Officer
Office of Strategic Programs (OSP) | Center for Drug Evaluation and Research (CDER) | FDA
Larry Callahan, PhD
Global Substance Registration System (G-SRS) | Office of Health Informatics
Office of Chief Scientist (OCS) | FDA
- Medicinal Product Identification
- Identification of Medicinal Products (IDMP)
- The Ginas Project: GInAS/GSRS site
- Unique Ingredient Identifier (UNII) search site
- This webinar is RAPS eligible for credit towards a participant’s RAC recertification.
- SOCRA 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.
- This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
- ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
- Attendance certificates are only available during the two weeks after the event. Real time attendance is required.
For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
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