- Date:
- September 4, 2024
- Time:
- 11:00 AM - 3:00 PM ET
Visit CDER Small Business and Industry Assistance Page
ABOUT THIS EVENT (Hosted by CDER SBIA)
The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. The target audience is entrepreneurs new to the FDA regulatory world that could benefit from support in better understanding when to contact the Agency during preclinical development. Additionally, there will be a Q&A session at the end of each session for the audience to ask questions.
INTENDED AUDIENCE
- Academic spin-off and early-stage companies (small businesses) developing therapies, devices, diagnostics, and digital health technologies.
- Researchers developing new anti-cancer drugs.
- Healthcare professionals developing new anti-cancer drugs.
TOPICS
- Regulatory resources and early engagement programs available at FDA Center (CBER, CDER, and CDRH)
- Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical guidance documents for early product development.
- Early-stage
- small molecule drug and biologic anticancer-drug development.
- cell and gene therapy anticancer-drug development.
- anticancer-device and diagnostic development.
- Q&A session with FDA regulators
FDA RESOURCES
CONTINUING EDUCATION
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been pre-approved by:
- RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- 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.
- SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
TECHNICAL INFORMATION
- To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
- Please contact info@sbiaevents.com for all technical questions.
- If you encounter any technical issues before or during the event, please visit the Technical Issues Support
- Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
