Steps to Comply with FDA Guidance
In December 2014, the FDA issued binding guidance for submissions of standardized nonclinical study data in SEND format. The requirement for NDA, ANDA, and certain BLA submissions compliant with FDA specifications begins on Dec 18, 2016. The requirement for INDs begins a year later.
Are you ready for this major change to your data collection and submission processes?
Will your solution provider guarantee that your study data will successfully pass the FDA’s Data Fitness checks? Do your CROs have the required expertise to submit SEND and FDA compliant datasets? Do they need help in modeling studies compliant with the SEND and FDA requirements? Will they coordinate with other CROs if studies are conducted at multiple sites or, if specialized data collection is done by other entities? Who will be responsible for data aggregation and harmonization? Will the CRO stand behind your submission given that failure can result in a “Refusal to File” by the FDA? Do you have access to the review tools used by the FDA?
Join our experts for a discussion of these topics. We will share recommended steps that large and small companies can take to build an effective readiness plan for compliance. Done correctly and in the right spirit, this can be a transformational process that will shave costs, minimize risks for your organization and reduce time to market.
For your convenience we will be providing the webinar again at the following times
|Session 2 in English||Japanese Session||German Session||French Session|
|Date: Jan 29, 2015||Date: Feb 6, 2015||Date: Feb 10, 2015||Date: Feb 11, 2015|
|Time: 11:00 AM EST||Time: 11:00 AM JST||Time: 03:00 PM CET||Time: 03:00 PM CET|
|Duration: 1 hour||Duration: 1 hour||Duration: 1 hour||Duration: 1 hour|
PC-based attendees Required: Windows® 7, Vista, XP or 2003 Server
Macintosh®-based attendees Required: Mac OS® X 10.5 or newer