Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.
This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development
How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.
Marketing application submissions, including NDAs, biologics license applications (BLAs), and premarket approvals (PMAs) in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you navigate submissions in the most efficient and effective way.
This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
This webinar highlights the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process.
Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?
A video overview of the valuable content that can be accessed as a DIA NOW user.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
How technology-based imaging improves quality and regulatory compliance, and how these improvements benefit sponsors.
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