Introduzione
For anyone interested in developing for and registering products in USA, this online training course will give all the required information about how to set-up your product development and successfully achieve registration with FDA.
For anyone interested in developing for and registering products in USA, this online training course will give all the required information about how to set-up your product development and successfully achieve registration with FDA.
Module 1
Advanced FDA Communications
a) Current Hot topic
b) Formal meetings with FDA
FDA Application type and dossier requirements
a) IND
b) New Drug Application: NDA, Art. 505 (b)(2), BLA
c) US generic products – the ANDA pathway
Module 2
FDA programs for Accelerated Development
Expedited pathways – Go Faster!
a) Go faster! Breakthrough Therapy, Fast track, Accelerated Approval and Priority Review
b) Overview of FDA incentives: vouchers, waivers and designations
c) Hot topics: How FDA managed drug-development during covid-19 outbreak?
Advanced regulatory affairs for Drug Development in the US
Orphan Drug Designation (ODD)
a) US ODD requirements
b) Comparison EU vs. US
DMF registration
working for pharmaceutical company and CROs whit specific interest in FDA regulation.
Participant experience
Basic regulatory knowledge would be preferred
Theorical explanation of US regulatory framework for drug development, practical tips and tricks for communications with FDA and examples on how to develop and register your product with FDA, including parallel development to EU.
Online Training – 2 modules
November 4th, 2020 2:00 pm – 6:00 pm CET
November 5th, 2020 2:00 pm – 6:00 pm CET
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 890,00* (until 14 October 2020)
Ordinary: € 1.100,00*
Freelance – Academy – Public Administration**: € 540,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.