"The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA..
(photo credit: outsourcing-pharma.com)
“The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies..
January 30-31, 2018 • DoubleTree by Hilton Philadelphia Center City • Philadelphia, PA
Why should you attend?
CBI’s 5th Annual Clinical Data Disclosure and Transparency conference will help to..
d-Wise appoints VP of d-Wise Europe and establishes German office in response to rapid international growth
- Demand for d-Wise’s clinical trials de-identification solutions soars following new regulatory demands in Europe
- The strategic choice of Frankfurt puts d-Wise in the centre of a major pharmaceutical..
"Companies that handle data are currently faced with constraints placed on them by data protection laws. The EU General Data Protection Regulation (GDPR) will come into effect on May of 2018 and..
"Whether you're an aspiring developer or an established one looking for a change, learning a programming language is a daunting task.
With an increase in demand for developers with statistical and..
As the life sciences industry prepares for compliance with EMA Policy 0070 and its requirements for the anonymization of shared clinical study reports, d-Wise has been previewing its powerful Blur..
PINEHURST (OCT. 2, 2017) — Forty North Carolina companies were honored on Monday, October 2 at Pinehurst Resort for being named as the N.C. Mid-Market Fast 40 list of 2017. Accounting firm Cherry..