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December 16, 2020
Dear International Colleague,
The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is announcing that registration is open for the CDER Compliance Conference. The event will occur on January 14, 2021, from 9:00 a.m. until 3:30 p.m. (Eastern Time). The conference is FREE.
TOPICS
- Drug importation requirements
- Drug Supply Chain Security Act implementation (DSCSA) implementation updates
- Compounding: Cleanrooms and cleanroom behaviors: why they matter
- Risk Evaluation and Mitigation Strategies (REMS) compliance program
In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation.
AUDIENCE
- Importers and exporters of pharmaceutical products
- Drug distribution supply chain
- Outsourcing facilities
- Boards of Pharmacy
- Compounders
- Pharmacists
- Regulatory affairs work on REMS
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 5 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.
If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and updates for regulated industry.
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