Office of Prescription Drug Promotion -

Core Launch Review Process

November 20, 2020 | 1:00 p.m. - 2:00 p.m. Eastern

This webinar is FREE.

REGISTER

This webinar will provide an overview of the upcoming changes to the Office of Prescription Drug Promotion’s (OPDP) Core Launch Review process. The updates to the Core Launch Review process are designed to improve efficiencies, maximize use of FDA’s resources, provide timely feedback to firms, and support our mission to help ensure prescription drug promotion is truthful, balanced, and accurately communicated.

LEARNING OBJECTIVES

Identify promotional materials that qualify for Core Launch Review within the OPDP Advisory Process
Understand the changes to the Core Launch Review process and incorporate those changes into existing promotional material development strategies
Utilize the various resources provided by OPDP to support the Core Launch Review process

INTENDED AUDIENCE

Ad/Promo Regulatory Operations Managers
Ad/Promo Submitters
Ad/Promo Publishers
Ad/Promo Consultants

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 credits 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.