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
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.
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.
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
·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
·Technical differences between US and EU
·Module 1 requirements
·Study reports and study tagging files
·Hands-on FDA eCTD compilation
Images from last edition in Barcelona!