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Join this essential webinar designed for early-stage companies, academic spin-offs, and researchers in the life sciences industry. Hosted by the FDA, this session offers a comprehensive introduction to the regulatory resources and programs available through the FDA’s Centers (CBER, CDER, and CDRH). The webinar is especially beneficial for entrepreneurs and healthcare professionals developing new anticancer therapies, devices, and diagnostics. Topics covered will include Chemistry, Manufacturing, and Controls (CMC), as well as non-clinical and clinical guidance for early product development. Attendees will have the opportunity to engage directly with FDA regulators during a Q&A session.
Who Should Attend:
- Academic spin-offs and early-stage companies in life sciences.
- Researchers and healthcare professionals focusing on anticancer drug development.
- Entrepreneurs new to the FDA regulatory environment.
Key Topics:
- Regulatory resources and early engagement programs at FDA.
- Guidance on small molecule drugs, biologics, cell and gene therapies, and diagnostic device development.
- Interactive Q&A with FDA regulators.
Continuing Education:
Real-time attendance is required to earn a certificate of attendance, which may be used for continuing education credits with professional organizations such as RAPS, SOCRA, SQA, and ACRP.
