| Promotional Submissions in eCTD Format – Grouped Submissions | August 31, 2021 | 1:00 - 2:00 p.m. Eastern | | | TOPICS - The purpose and benefits of grouped submissions in eCTD format to the Office of Prescription Drug Promotion (OPDP)
- The content and structure of grouped submissions to OPDP in eCTD format
- Common errors associated with grouped submissions and how to avoid them
| AUDIENCE - Regulatory affairs professionals
- Submitters
- Publishers who submit promotional materials to CDER's Office of Prescription Drug Promotion (OPDP) in eCTD format
| | 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: - has been pre-approved by RAPS as eligible for credits (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. | | | |
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