SBIA Webinar | Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics

Mark your calendar!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics Thursday, January 27, 2022 9:00 AM - 10:30 AM  ET Register 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 FDA SPEAKER Ron Fitzmartin, PhD, MBA  Senior Informatics Advisor  Office of the Director Center for Biologics Evaluation and Research (CBER) | FDA Ta-Jen Chen  Senior Project Management Officer  Office of Strategic Programs (OSP) Center for Drug Evaluation and Research (CDER) | FDA Vada Perkins, MSc  Executive Director, Regulatory Policy & Innovation Bayer Pharmaceuticals European Federation Pharmaceutical Industries & Associations Technology Group Pharmaceutical Research and Manufacturing Association IT Working Group ICH M2 EFPIA Topic Lead  ISO TC 215 WG 6 IDMP Co-chair RESOURCES Identification of Medicinal Products (IDMP) International Organization for Standardization (ISO) Identification of Medicinal Products: Path to Global Implementation – Webinar - June 11, 2021 TOPICS 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 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 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: 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. has been 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. has been 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. has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA