Registration Open: OTC Monograph Reform in the CARES Act: Safety Orders

If your email program has trouble displaying this email, view as a webpage. January 25, 2021 Dear International Colleague, The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is announcing that registration is open for the CDER Small Business and Industry Assistance Webinar: OTC Monograph Reform in the CARES Act: Safety Orders. The event will occur on January 27, 2021, from 1:00 p.m. until 2:00 p.m. (Eastern Time). The webinar is FREE. Register TOPICS This webinar will provide an overview of nonprescription drugs, Over-the-Counter (OTC) Monograph Reform, and how FDA identifies and evaluates safety issues.  The webinar will also explain the procedure for FDA-initiated administrative orders to address safety issues and how the public can participate in the administrative order process. AUDIENCE General public with an interest in nonprescription (also known as over-the-counter or OTC) drugs Regulatory affairs professionals involved in the development or marketing of OTC drugs Foreign regulators following the development or marketing of OTC drugs Consultants focused on OTC drug development or marketing Clinical research coordinators  Importers of OTC drugs CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course: has been pre-approved by RAPS as eligible for up to 1 credit 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 0.25 non-GCP or non-GLP units 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. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707. The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and updates for regulated industry.

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