16 April 2018 (Verona, Italy) – CROS NT is joining Asphalion as a contributor to the FDA Open Seminar taking place this June in Barcelona, Spain. The “FDA Open Seminar – All you need to know!” is an event that presents all important aspects of FDA Regulatory Affairs.
CROS NT Director of Project Management, Marta Zanus, is set to speak on Thursday, 7th of June with a presentation on Integrated Summaries of Safety and Efficacy (ISS/ISE). The speech is titled “Tips for meeting statistics and data management challenges faced by Sponsors” and looks at what to consider when planning ISS/ISE strategy and when to start planning as well as identifying risks related to ISS/ISE.
The seminar is also going to address the basics of FDA electronic submission requirements given several important eCTD deadlines in 2018.
For more information, download the FDA Open Seminar PDF Fact Sheet.