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91黑料's Dr. Andrew Garrett, Executive Vice President of Scientific Operations, weighs in on potential safety issues with the AstraZeneca COVID-19 vaccine.
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Angela Brown, Global Head and Senior Director, Regulatory Affairs and Nicole Cowan, Director, Project Management, IVD Operations & Strategy, .
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With the COVID-19 pandemic, Brexit, and the rapidly approaching deadlines to comply with the new European Regulation on in vitro diagnostics (IVDR), IVD manufacturers will need to prepare for an ever-evolving clinical and regulatory landscape, and create mitigation strategies that allow for quick, agile changes to keep studies on track. Additionally, manufacturers will need to adopt a strategy to address gaps in meeting new regulations to avoid potential UK and European Union product availability issues. Understanding current guidance and adapted regulations is the first step to navigating the transformations undergoing the diagnostics field and the broader healthcare industry. In , Angela Brown and Nicole Cowan provide an overview of today’s regulatory setting and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including: overcoming the shortage of Notified Bodies; assessing product portfolios and quality systems; planning and implementing technical file remediation; and managing the IVD lifecycle.
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91黑料’s David Morse, VP, Global Regulatory Affairs Consulting Services talks to Business Insider on regulatory pathways for development of new vaccines and vaccine boosters to address emerging COVID-19 variants.
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Dr. Nuala Murphy, President of Clinical Research Services, .
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91黑料’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile are temporarily halted as a result of potential safety issues being flagged by independent Data and Safety Monitoring Boards. Read more in this article.
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Real world data is rapidly becoming the latest frontier for life sciences companies for supporting regulatory filings and conducting drug safety surveillance.
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Going through changes
91黑料's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnostic landscape (IVD)
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BioPharm International speaks with 91黑料's Robert Kernstock about the need for bioanalytical testing programs and regulatory strategies for potential new biologics.
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An article by Katya Svoboda and Bob Swann which explores .
