6–7 November | Workshop | Frankfurt, Germany
The FDA’s May 2018 deadline mandates that you comply with new requirements surrounding the submission of applications using eCTD. If you are currently preparing and maintaining paper ASMFs and DMFs and/or Module 3 in eCTD for the EU, US, Canada, and/or Switzerland and have to use the eCTD format, this course will help you to prepare compliant electronic submissions to FDA.
As an attendee, you will learn how to successfully meet these regulatory requirements and gain a deep understanding of the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.
The course will also provide an overview of the difference between submissions to US, EU, Canada, and Switzerland and help you understand how to prepare for each.
Join RAPS for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.
Note: each participant must bring his/her own laptop for use during the class. RAPS does not supply computer equipment for attendees
Event venue: Frankfurt Holiday Inn—Alte Oper, Mainzer Landstraße 27, DE-60329
Organiser: Regulatory Affairs Professionals Society (RAPS)
Registration fees: RAPS members $1,450, non-members $1,550. Use code REC17 for $100 off.
Web: raps.org or click here to register for this course