Regulated Bioanalysis Workshop:
Requirements and Expectations
June 30, 2020
This event is FREE to attend
Virtual Online Attendance Only
This training is focused on presenting an overview of how FDA’s Center for Drug Evaluation and Research approaches different issues in bioanalysis. The audience will gain and deeper and broader understanding of how bioanalysis must be performed to adequately support regulated activities and how FDA performs bioanalysis to further the agency’s mission and support regulated industry. Attendees will have the opportunity to learn firsthand how the offices that review and conduct bioanalysis conduct their work in this field.
- Bioanalytical method validation: history, process, and regulatory perspectives
- Regulated bioanalysis for large molecules
- Regulated bioanalysis for small molecules
- Drugs and biologics
- Bioanalysis of unstable analytes
- Repeat analysis
- Endogenous compound bioanalysis
- Overview of immunogenicity inspections
- Considerations on ex vivo conversion of prodrugs during bioanalysis
- Bioanalysis of the dried blood spot (DBS) by mass spectrometry for the FDA regulated clinical studies
- What meta-analysis can tell you about the performance of bioanalytical methods
- Office of Study Integrity and Surveillance’s (OSIS) Collaboration, Risk Evaluation and Surveillance Team (CREST) Site Selection Model Overview
- Case study: bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection
Who Should Attend?
This event is intended for:
- Regulatory affairs professionals who submit INDs, NDAs, BLAs and ANDAs that include bioanalytical study data
- Researchers involved in regulated bioanalysis
- Sponsors planning studies involving bioanalysis
- Industry professionals associated analytical laboratories that involve bioanalysis
Continuing Education Credit
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
- is eligible for SOCRA credit 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. Candidate must provide documentation of participation.
- 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.
- Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
The agenda may change over time. New versions will be linked here. The current version is version 3, updated on May 22, 2020.
The speaker biographies document is under development and will be posted here when it is completed.
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 5 business days.
Please select the correct room based on your LAST NAME.
The above links will become active the day of the event.
The above rooms will open ~15 minutes before each day begins.
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:
If you encounter any technical issues, visit the Technical Issues Support Page
The ZIP file 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: