FREE WEBINAR on FDA REGULATORY AFFAIRS
September 20th 2017, 15:00h CEST
Based
on the successful FDA Open Seminar conference series, we’ll host a 2 hour
crash course webinar. You will hear about the latest US drug regulation
news and will obtain a solid introduction into FDA Regulatory Affairs.
Don’t
miss:
1. FDA HOT TOPICS
- Announcement and implications of the new 2018 NDA and ANDA User Fees (PDUFA VI
and GDUFA II) - Establishment Registration Requirements
- FDA Foreign Inspection Program
2. FDA Introduction and Overview
3. Obligations and Regulatory Options during Drug Development
- Meetings with FDA
- IND Application
- US Agent Requirements
4. Drug Registration in the US – Pathways and Dossiers
- NDA 505(b)(1) and 505(b)(2)
- BLA
- ANDA
- DMF
5. eCTD – Latest Requirements!
- Dates and Deadlines
- Strategy for Compliance
6. Questions and Answers Session
Your
speakers will be ASPHALION’s US agent Mr. Bruce Thompson of REGULIANCE, with 25 years of FDA
experience, as well as ASPHALION’s own FDA expert
team.
