FDA Regulatory Affairs Webinar - Asphalion

Описание: The latest US drug regulation news a solid introduction into FDA Regulatory Affairs by Reguliance and Asphalion.

REGULIANCE is a regulatory consulting firm focused on US FDA-related pharmaceutical and biopharmaceutical development and commercialization. Founded in 2002, Reguliance provides an array of services including: FDA regulatory insight, strategy, and support, to small- and medium-size domestic and foreign companies. http://reguliance.com/

ASPHALION is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona and Munich. We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies. http://www.asphalion.com/

Topics & mapping:

1. Welcome & Introduction of REGULIANCE and ASPHALION and their services - 0:00:00 h

2. FDA and What’s Hot - 0:03:30 h
a. General introduction to FDA
b. Announcement and implications of the new 2018 NDA and
ANDA User Fees (PDUFA VI and GDUFA II)
c. Establishment Registration Requirements
d. FDA Foreign Inspection Program

3. Obligations and Regulatory Options during Drug Development - 0:25:00 h
a. Meetings with FDA
b. IND Application
c. US Agent Requirements
d. DMF

4. Drug Registration in the US - Pathways and Dossiers
a. NDA 505(b)(1) and 505(b)(2) - 1:26:00 h
b. BLA
c. ANDA

5. eCTD Latest Requirements - 2:08:30 h
a. Dates and Deadlines
b. Strategy for Compliance

6. Questions (via Chat) and Answers 2:15:40 h