200 Stuart Street
Boston, Massachusetts 02116
You may attend in-person or virtually. This event is FREE.
About This Event
CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA. FDA speakers will be available to answer questions one-on-one at the end of each day.
Drugs track: Will focus on the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs).
Devices track: Will address globalization, harmonization, and standardization of medical device regulation.
- Plenary Session: Navigating the World of Combination Products
- A Medical Officer’s Approach to NDA/BLA Review
- Regulatory Highlights for Biosimilars and Interchangeables
- Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements
- Building Quality Clinical Data into Premarket Approval Applications (PMAs)
- Doug Throckmorton, MD | Deputy Director for Regulatory Affairs | CDER | FDA
- William H. Maisel, MD, MPH | Director, Office of Device Evaluation | CDRH | FDA
- Joseph Matrisciano Jr. | Director, New England District Office | Office of Regulatory Affairs | FDA
Who should attend?
Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submissions and globalization, harmonization, and standardization of medical device regulation.
- Newcomers, managers, or directors in the drug or medical device industries
- Regulatory affairs
- Research and development
- Quality assurance and control
- Development and preparation of submissions
Continuing Education Credit
- This course is eligible for 11 CE credits for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE announcement for complete information.
- This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- This event 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.
- ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
- Attendance is required for attendance certificates which are only available during the two weeks after the event.
FDA Sponsoring Offices
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)
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:
For technical assistance with the webcast, please email at firstname.lastname@example.org.