FDA has a whole slew of new rules on how it wants to communicate with industry. Need a crash course?
Get ready for FDA's new and evolving electronic requirements with this two-day, must-attend conference. You'll walk away with a winning formula for eliminating communication bottlenecks with the FDA.
Hear straight from top FDA insiders — Beth Duvall-Miller (CDER), Steven Gitterman (CDER), Robert Gatling (CDRH), Joseph Montgomery (CBER) and Toni Stefano (CBER) — all key officials in FDA's electronic initiatives.
New FDA Gateway Program, Elabeling, Esubmissions, Computer Validation and More!
Discover how to use FDA's Gateway Program — a portal through which the industry will communicate with all FDA centers — to communicate successfully with the FDA. Learn from 17 leading industry pros, including five top FDA officials, how to use the latest electronic tools to speed review of your submissions and get your product to market faster.
Register today for pre-conference workshops and 12 interactive conference sessions covering —
- Clinical Data Interchange Standards (CDISC)
- NDA, ANDA, IND and BLA submissions
- Electronic records and signatures
- Adverse event reporting
- Post-marketing commitments
- Inspections and audit trails
- Risk-based computer validation
- CTD preparation
Minimum system requirements for viewing webcast: P3 500Mhz with 8MB video memory with Windows Media Player or Real Player (newestversions preferred)