The Advanced FDA Regulatory Affairs online training course will take place on the 4th and 5th of November, 2020 and it will provide you with an insight into the required information on how to set up your product development and successfully get an FDA registration approval.
The event is organized by Life Science Academy and the lecturers are Lidia Cánovas, Director of Regulatory Affairs at Asphalion, and Bruce Thompson, Principal at Reguliance (an Asphalion Partner).
The programme encompasses the understanding of advanced FDA Communications (scope of meetings, meeting types/ formats/ request/ package, type B meetings, FDA preliminary responses, etc.) and FDA application types and dossier requirements (IND; New Drug Application: NDA, Art. 505 (b)(2), BLA; US generic products – the ANDA pathway). FDA programmes for accelerated development will also be covered, as well as advanced regulatory affairs for Drug Development in the US. Besides, managing strategies and procedure guidelines will be provided. A pragmatic point of view will be given through business cases and questions from the audience.
The online training course is aimed to specialists from pharmaceutical companies and CROs with a specific interest in FDA regulations, such as regulatory affairs officers or managers, technicians, quality managers, development pharmacists, pharmacovigilance professionals or project managers.
At the end of the training, participants will be able to understand communication programmes with the FDA during development, have a clear overview of the FDA accelerated programmes and be able to identify the main differences between the EU and the US in terms of drug development.
Register before October 21st, 2020 and get an early bird discount!
For further information, please contact us at info@asphalion.com or visit this webpage.
