Regulatory Affairs, Safety, and Clinical R&D are traditionally managed as three separate departments, each with their own business processes and software systems. As the number of these touch points increase, it motivates the desire and urgency for better integration in order to operate more nimbly, reduce data discrepancies, and lower costs.
The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This Webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included.
Population-based RWD are increasingly used by US and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.
In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.
UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.
Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.
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.
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