SBIA: Register for the Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups

FDA | CDER | Small Business and Industry Assistance CONFERENCES Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups March 30-31, 2021 This workshop is FREE. Registration and Agenda TOPICS Federal Resources for Innovative Cancer Startups: More than Just Funding! CMC Considerations for CAR T Cell Product and Oncolytic Viral Product Development Preclinical Considerations for Cell and Gene Therapy Products, An FDA Perspective  Designing First-in-Human Trials for Small Molecules and Biologics Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal See more topics on the workshop agenda... This conference will provide guidance on the steps and potential pitfalls of early drug development for anticancer therapies.   INTENDED AUDIENCE Academic entrepreneurs and founders of small start-up oncology companies. 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 credits (appropriate to real-time attendance) 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 1 non-GCP or non-GLP unit 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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