FDA REdI Annual Conference
August 25, 26, 27 & 28, 2020
This event is FREE to attend
Virtual Attendance Only:
This event will be webcasted with blended learning
to optimize safety during the public health emergency.
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.
This event is a collaboration between the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE).
- Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Updates
- Post Approval Regulatory Consideration for Changes to Manufacturing Process and Facilities
- Study Data Technical Rejection Criteria
- Office of New Drug (OND) Reorganization
- 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
- Using FDA Resources to learn how to comply with the applicable medical device regulatory responsibilities
- Benefit-risk principles to the total product life cycle of medical devices.
- 510(k) Program: including device modifications and the safety and performance pathway
- De Novo Classification
- Cybersecurity in Medical Devices
- FDA Quality System, namely the subsystems of Design Controls and Production/Process Controls, and risk management
- FDA manufacturing program, Case for Quality
- Medical Device Single Audit Program a walkthrough of the electronic medical device reporting system
- Medical Device Inspections
Who Should Attend:
- Regulatory affairs professionals
- Development and preparation of submissions
- Newcomers, managers, or directors in the drug or medical device industries
- Research and development
- 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 Credit
- 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.
- Real-time attendance is required for attendance certificates which are only available during the three weeks after the event.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is Version 6, updated on August 9.
This PDF file contains brief biographies of the FDA speakers participating in the conference. The biographies document is still under development and will be linked here as soon as it is ready.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.
The links below to the Adobe Connect room for each track will be activated shortly before the event begins.
Please select the correct room based on your LAST NAME.
The above links will becoeme active the day of the event.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
The ZIP files above will be available for download 24 hours before the event.
The above link will become active at the conclusion of the event.
If you have questions regarding the content of the event or other CDER-specific information, please: