Webinar | May 15, 2015

CDISC Standards Briefing: Get Ready for FDA Submissions

Source: Bioclinica

Duration: 1 hour
Speaker: Jennifer Price, Director, Clinical Solutions, eClinical



The FDA issued draft guidance this past February on study data in conformance with CDISC standards.

Will you be ready for FDA submissions when that guidance goes into effect?

It has taken a decade of expertise and infrastructure to make CDISC the global language of clinical research − now used in 90 countries. Recent initiatives extend support for acquisition, exchange, submission and archive of clinical research data and metadata.

If you have questions about the most recent CDISC updates and what's needed for future regulatory submission, this webinar will provide answers.

Long-time data standards proponent Jennifer Price will provide advice that can be put into practice now. She will also share insights on what is coming next on the standards front. It is timed to follow the CDISC International Interchange 2014, where CDISC users and creators will be gathering with regulatory agencies and industry partners to discuss core standards implementation and what's coming. If you not can't make it to the Interchange this year, no worries. This webinar is the next-best-thing to being there!

Join Jennifer as she explores the most talked about conference topics, including:

  • Highlights from keynote speaker, Eileen Navarro-Almario, MD, FDA Lead Medical Officer, on Embracing a Changing Landscape
  • Real-life implementation examples
  • CDASH, SDTM, Device, and Controlled Terminology Working Group updates
  • CDISC Partnerships (IDG, NCI, CFAST) update
  • CDISC Therapeutic Area Standards (Alzheimer's Disease, Pain, Parkinson's Disease, Polycystic Kidney Disease, Tuberculosis, Asthma) updates

Don't miss this opportunity to learn about compliance with CDISC standards in future FDA submissions.