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

Event Title
Webinar: Monograph reform is here! Learn what to expect and how to prepare.
May 29, 2020

Scheduled
Date:
May 29, 2020
Time:
1:00 PM - 2:00 PM ET

View Slides

This webinar provides a general overview of monograph reform, how it impacts FDA’s regulation of monograph products, and how it affects industry and the public.  The webinar will address most commonly asked questions.

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

FDA SPEAKERS

Theresa M. Michele, MD
Director, Office of Nonprescription Drugs | CDER | FDA

Karen M. Mahoney, MD
Deputy Director, Office of Nonprescription Drugs | CDER | FDA

FDA RESOURCES

CONTINUING EDUCATION

This course:

  • 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.
  • 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 medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.

QUESTIONS

Please contact CDERSBIA@fda.hhs.gov for all technical questions.

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Event Materials

Title File Type/Size
Monograph Reform is Here! pdf (528.80 KB)
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