Following its large success in 2010 and 2015, ASPHALION is excited to announce a new edition of its FDA OPEN SEMINAR to take place in spring 2016. This time, the seminar will be further improved: ASPHALION has teamed up with its partner EXTEDO to offer a practical eCTD workshop.
On the first day, presented jointly with ASPHALION’s US agent Bruce Thompson of REGULIANCE, the seminar will offer in-depth insight into the critical points of FDA projects. All important aspects of FDA regulatory affairs will be covered: interactions with FDA during development, strategy for Orphan Drugs and Paediatric Medicines, pre-submission meetings, IND/NDA/505(b)(2)/ANDA/DMF dossier requirements, submission procedures, theory and practise of eSubmission, and much more.
On the second day, EXTEDO will offer a hands-on training for eCTD publishing to FDA. This will be a unique opportunity to apply your new knowledge and to build (your
first) FDA eCTD submission.
During these two days, ASPHALION, REGULIANCE and EXTEDO will share their knowledge from many years of experience with FDA submissions: from initial strategy, dossier submission and registration procedure, till the successful market entry and maintenance phase.
9th March: FDA Seminar
·FDA affairs during development
·FDA application types and dossier requirements
·Post approval activities
·Comparison and conversion: FDA vs. EMA
·Plenty of time for questions and answers
10th March: eCTD Training
·Practical FDA eCTD workshop using EXTEDO?s eCTDmanager
·Technical differences between US and EU submissions
·Module 1 requirements
·Study reports and study tagging files
·Hands-on FDA eCTD compilation