This year’s DIA eRegulatory and Intelligence conference in Philadelphia, PA May 11-13 is the definitive source of information on the FDA’s transition to a new Module 1.
The Agency is scheduled to provide an M1 implementation update covering timelines and expectations on Tuesday, May 12th during Session 1, Track 2. The session is scheduled to run 8:30 a.m. – 10 a.m.
GlobalSubmit’s Rob Connelly is also scheduled to speak during this session. His presentation is titled “Using the New FDA Module 1.” Mr. Connelly will use visuals from GlobalSubmit’s eCTD publishing software to demonstrate how the M1 changes will impact industry during submission compilation. GlobalSubmit PUBLISH is already compliant with the technology the FDA plans to implement.