Webinar: Monograph reform is here! Learn what to expect and how to prepare. - 05/29/2020 - 05/29/2020 | FDA

Webinar: Monograph reform is here! Learn what to expect and how to prepare. - 05/29/2020 - 05/29/2020 | FDA

CDER Small Business and Industry Assistance Webinar Monograph Reform Is Here! Learn What to Expect and how to Prepare

Friday, May 29, 2020 | 1:00 PM - 2:00 PM ET This webinar is FREE.

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TOPICS The current system of regulating over-the counter drugs and why there was a need for reform of the monograph system. The key elements of the Monograph Reform legislation including Monograph Order Requests and Administrative Orders and the impact on regulation of drugs that meet monograph conditions. How FDA will transition all the monographs into Administrative Orders whether those monographs are final monographs or tentative final monographs. How sponsors who have over-the-counter drugs might consider preparing for Monograph Reform INTENDED AUDIENCE Regulatory affairs professionals working on new drugs or dosage forms for the consumer, known as over-the-counter (OTC) drugs or nonprescription drugs Clinical research coordinators Consultants focused on development of OTC drugs or nonprescription drugs for the consumer Foreign regulators following the development of OTC drugs or nonprescription drugs for the consumer Importers of OTC drugs or nonprescription drugs for the consumer General public with an interest in OTC or nonprescription drugs CONTINUING EDUCATION This course: 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 RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. 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.  Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.