Regulatory Webinars
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psiXchange: Intelligent, Automated Safety Reporting
3/25/2024
Discover how to completely automate your safety reporting and significantly reduce your effort and costs while improving compliance.
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Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence
3/15/2024
Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.
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Avance Clinical Expands Pharmaceutical Safety Services With Oracle Argus
3/11/2024
Find out what happened after this contract research organization turned to Oracle Argus for compliant clinical trial management.
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Managing A Continually Evolving Disclosure Landscape
2/20/2024
Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.
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Exploring The Interactions Between Validation, Technology Transfer
1/24/2024
Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.
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Practical Applications Of ICH E6(R3): What Do We Need To DO?
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Early Access Programs: What They Are And How To Plan For Them
12/5/2023
Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.
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EU CTR: An Introduction To European Clinical Trial Transparency
12/4/2023
Listen in as regulatory expert Pierre-Frederic Omnes takes viewers through an overview of the European Clinical Trial Regulation (EU CTR) and its impact on clinical trials.
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Navigating The Unique Attributes Of Psychedelic Drug Development
11/21/2023
This session gives an overview of the recently published draft FDA guidance on psychedelics and how to efficiently adapt the recommendations for early phase clinical development.
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Navigating The Process Of Technology Transfer
11/14/2023
Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.