Regulatory Webinars
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Are You Really Ready For Your End Of Phase 2 (EOP2) Meeting?
4/21/2020
The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.
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The Challenges Of eCTD Implementation In Small Company And Academic Settings
3/6/2020
This webinar recording will give an overview of challenges and successes of implementation of eCTD in both a small biotech setting and in academia, as these areas of industry face additional challenges that most midsize and large companies may not have.
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Veeva SiteVault: eRegulatory For Clinical Research Sites
1/9/2020
Watch a 3-minute video to see how clinical research sites can seamlessly manage regulatory documents and process in SiteVault to reduce administrative burden, speed study activation, and improve visibility.
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Reporting To ClinicalTrials.gov: Reflections And Challenges
11/7/2019
Who can reflect better on this topic than Dr. Deborah Zarin, former director of ClinicalTrials.gov? Dr. Zarin, now with the MRCT Center, shared her experiences and advice at the recent EXTRA: TrialScope Transparency Experience.
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Integrating Regulatory Affairs, Safety, And Clinical R&D To Manage Data And Drive Value Across the Enterprise
6/19/2019
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.
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Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle
6/19/2019
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.
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The Value Of RWD In Safety Signal Refinement
5/24/2019
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.
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Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
5/7/2019
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.
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Risk Evaluation And Mitigation Strategy (REMS) Overview
4/29/2019
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.
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Taking The Fear Out Of Software Implementation
2/26/2019
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.