Tuesday, June 19, 2018
10:00am - 2:00pm (Eastern)
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
On June 19, 2018 FDA provided an overview of Postmarketing Drug Safety Inspections for products regulated by the Center for Drug Evaluation and Research (CDER). These inspections include the Postmarketing Adverse Drug Experience (PADE) and Risk Evaluation and Mitigation Strategies (REMS) programs. During this extended webinar, we provided an overview of the relevant laws and regulations, described the PADE and REMS programs, and discussed points to consider for inspection.
Session One: Postmarketing Adverse Drug Experience (PADE) Inspections
- Guidance for Industry: Compliance Policy for Combination Product Postmarketing Safety Reporting
- Guidance for Industry: Providing Regulatory Submissions In Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
- Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without An Approved Application
Session Two: Risk Evaluation and Mitigation Strategies (REMS) Inspections
- Risk Evaluation and Mitigation Strategies: Modifications and Revisions â Guidance for Industry (April 2015)
- REPORT: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) (Sept 2014)
- Risk Evaluation and Mitigation Strategies Compliance Program Manual
Session Three: Inspection Readiness
- 2018 Investigations Operations Manual (IOM)
- Bioresearch Monitoring Program (BIMO) Compliance Programs
- PADE Compliance Program
- REMS Compliance Program
Resources For You
For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
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