eventscribe

The eventScribe Educational Program Planner system gives you access to information on sessions, special events, and the conference venue. Take a look at hotel maps to familiarize yourself with the venue, read biographies of our plenary speakers, and download handouts and resources for your sessions.

close this panel

SUBMIT FEEDBACKfeedback icon

Please enter any improvements, suggestions, or comments for the JSM Proceedings.

Comments


close this panel
support

Technical Support


Phone: (410) 638-9239

Fax: (410) 638-6108

GoToMeeting: Meet Now!

Web: www.CadmiumCD.com

Submit Support Ticket


close this panel
‹‹ Go Back

Marly Gotti

Biogen



‹‹ Go Back

Please enter your access key

The asset you are trying to access is locked for premium users. Please enter your access key to unlock.


Email This Presentation:

From:

To:

Subject:

Body:

←Back IconGems-Print

282 – 282- Tools to Enable the Use of R by the Biopharmaceutical Industry in a Regulatory Setting

Paving the Way for Regulatory Submissions Using R: The Risk Assessment Application

Sponsor:
Keywords: risk assessment, riskmetric, shiny, R, metric, validation

Marly Gotti

Biogen

In recent years, R has gained significant popularity as a statistical software in the academia mainly because it is free, open source, and vastly used in academic research. This popularity has reached the health sector and other regulated industries. As a consequence, an avalanche of concerns has been raised by statisticians, statistical programmers, quality assurance teams and others within the pharmaceutical industry about the use of R and selected R packages as primary tools for statistical analysis for regulatory submission work. To address such concerns, the R Consortium set in motion the R Validation Hub, a collaboration to support the adoption of R within a bio-pharmaceutical regulatory setting. In this paper, we will introduce the Risk Assessment Shiny Application, one of the tools currently in development by the R Validation Hub to aid in the validation of R packages in regulated environments.

"eventScribe", the eventScribe logo, "Cadmium", and the Cadmium logo are trademarks of Cadmium LLC, and may not be copied, imitated or used, in whole or in part, without prior written permission from Cadmium. The appearance of these proceedings, customized graphics that are unique to these proceedings, and customized scripts are the service mark, trademark and/or trade dress of Cadmium and may not be copied, imitated or used, in whole or in part, without prior written notification. All other trademarks, slogans, company names or logos are the property of their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, owner, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by Cadmium.

As a user you may provide Cadmium with feedback. Any ideas or suggestions you provide through any feedback mechanisms on these proceedings may be used by Cadmium, at our sole discretion, including future modifications to the eventScribe product. You hereby grant to Cadmium and our assigns a perpetual, worldwide, fully transferable, sublicensable, irrevocable, royalty free license to use, reproduce, modify, create derivative works from, distribute, and display the feedback in any manner and for any purpose.

© 2021 Cadmium