Regulatory Education for Industry (REdI) Annual Conference - 08/25/2020 - 08/28/2020 | FDA

Regulatory Education for Industry (REdI) Annual Conference - 08/25/2020 - 08/28/2020 | FDA

Regulatory Education for Industry (REdI) Annual Conference Aug. 25-28, 2020 | Webcast This workshop is FREE.

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Please select the track of your interest: drugs or devices. The drugs track will be held on August 25th and 26th. The devices track will be held on August 27th and 28th.

Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions. Drugs Track: This year’s agenda will complete our series of the regulatory timeline which we started in REdI 2018 We will focus on “Post Approval Considerations” as we address the regulatory aspects of selected topics and utilize case studies to exemplify best practices within those areas. Devices Track: A core theme of this program is to consider the role of risk, and risk-benefit into regulatory decisions to help advance the development of safe and effective medical devices.  This program also uses examples and specific case studies to provide a hands-on experience to reinforce the regulatory principles described.

Who should attend? Regulatory affairs professionals Development and preparation of submissions Newcomers, managers, or directors in the drug or medical device industries Quality assurance and control Medical device stakeholders who want to find online resources that explain premarket and postmarket regulatory framework for medical devices Regulatory affairs professionals seeking to submit new or novel medical device regulatory submissions, including premarket notifications (510(k)s) and De Novos. Manufacturers and researchers who are responsible for ensuring the cybersecurity of their medical devices. Manufacturers and regulary affairs professionals seeking to enhance their knowledge about the FDA Quality System (21 CFR 820) and applicable subsystems Global manufacturers who are seeking to harmonize their manufacturing activities to comply with multiple country regulatory bodies.

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 12 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.

Drugs Track Topics

-Drug Supply Chain Security Act (DSCSA) Updates

-Post Approval Regulatory Consideration for Changes to Manufacturing Process and Facilities

-Overview of post-approval Chemistry, Manufacture, and Controls (CMC) changes to NDAs

-Post-Approval Submission of Promotional Materials to the Office of Prescription Drug Promotion

Devices Track Topics

-Benefit-risk principles to the total product life cycle of medical devices.

-510(k) Program:  including device modifications and the safety and performance pathway

-FDA Quality System, namely the subsystems of Design Controls and Production/Process Controls, and risk management

FDA manufacturing program,

-Medical Device Inspections