lunes, 15 de agosto de 2016

CDER SBIA Webinar - Submitting REMS in SPL Format: August 24, 2016

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
On August 24, 2016, 1 PM EST, CDER will host a LIVE webinar titled: Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format: What You Need to Know

This 60 minute webinar will provide information regarding the FDA’s new capability of receiving REMS data in SPL format. This project is a direct result of requests from industry and health care providers for more standardization in REMS programs. It also meets a commitment under the Prescription Drug User Fee Act to carry out certain priority projects to standardize REMS.

Specifically, the presentation will address topics such as:
- Why submit REMS data in SPL? -
- How to submit REMS data in SPL? -
- Where to find helpful resources -
- Tips for successful submissions -

We are very interested in addressing any questions or concerns and we will have a live Q and A session after the presentation.

This event has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.

Related Resources:

For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707

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