Discover the course
ONLINE TRAINING: Advanced FDA Regulatory Affairs
In-depth review of US Regulatory Affairs environment
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.
Advanced FDA Communications
a) Current Hot topic
- Impact of covid-19
- Update on the programs FDA is working on: cooperation program with other countries for drug approval Project Orbis
b) Formal meetings with FDA
- Scope of meetings
- Meeting types
- Meeting formats
- Type B meetings
- Meeting Request
- Meeting package
- FDA preliminary responses
- How are meetings conducted
FDA Application type and dossier requirements
b) New Drug Application: NDA, Art. 505 (b)(2), BLA
c) US generic products – the ANDA pathway
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
The online training will be in English
Lidia has a Pharmacy and MBA degree.
She has more than fifteen years overall experience in pharmaceutical industry, most of which as Regulatory Affairs Director, but she has also covered the role of Vice-Director for Research and Development. She has worked at Asphalion for ten years as General Manager and Director of Regulatory Affairs. In this second role, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.
Bruce is an independent consultant with over 20 years’ experience in the pharmaceutical and biotech industries, possessing practical skills in the details of product development planning, regulatory strategy, and project management. He is Principal of Reguliance, which he founded in 2002. He has previous experience in the pharmaceutical industry as Managing Director, Director of Regulatory Affairs and Acting Director for US Regulatory Affairs for several companies for 10 years. He is member of the American Society of Gene & Cell Therapy (ASGCT), the Licensing Executives Society (LES) and the Regulatory Affairs Professionals Society – RAPS (certified 1994).
- Regulatory Affairs Manager, Officer and Specialist
- Quality Manager
- Development Pharmacist
- Pharmacovigilance Manager
- Project Manager
working for pharmaceutical company and CROs whit specific interest in FDA regulation.
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 CEST
November 5th, 2020 2:00 pm – 6:00 pm CEST
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 21 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: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Wednesday, October 21, 2020
At the end of the training, you will be able to
Understand communication programs with FDA during development
Have a clear overview of FDA accelerated programs
Be able to identify the main differences between EU and US in drug development