The Importance of Quality Data and Data Fitness in a Regulatory Submission, Upcoming Webinar Hosted by Xtalks
TORONTO (PRWEB) October 15, 2019 -- Only 50 percent of new NME (New Molecular Entity) applications are approved on the first submission to the US Food and Drug Administration (FDA) and there is a median delay of 435 days to approval following the first unsuccessful submission. Additionally, with the increased use of the JumpStart data fitness review by the FDA, there are an increasing number of Information Requests (IRs) made by the FDA to resolve data issues during the submission process. IRs are likely to increase further with the introduction of a risk-based approach to monitoring and this may result in an increase in data fitness issues.
Failures occur for a variety of reasons relating to data conformance, data quality, and statistical approaches affecting conclusions on efficacy and safety.
Answering IRs and resubmitting failed applications take time and money, delaying market approval of vital new drugs to patients. With awareness of these common reasons for submission failure, it is possible to improve the chances of first-time submission approval.
In this live webinar taking place on Monday, October 28, 2019 at 11am EDT (3pm GMT/UK), three experts from Quanticate will discuss three strategies to ensure data fitness in regulatory submissions:
1. Study data conformance
- CDSIC and eCTD compliance
2. Data quality oversight
- Data monitoring through Centralized Statistical Monitoring (CSM)
3. Statistical approaches and inferential conclusions
- Use of sensitivity analyses
The featured speakers from Quanticate are listed below:
- Karen Ooms, Executive Vice President, Head of Statistics
- Paula Finch, Senior Vice President, Project Delivery
- Santosh Tymms, Statistician II
For more information or to register for this event, visit The Importance of Quality Data and Data Fitness in a Regulatory Submission.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Candice Tang, Xtalks, http://www.xtalks.com, 1 (416) 977-6555, [email protected]
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