RUSSIA: Registration of Generics and Biosimilars
Termindetails
Wann
von 09:00 bis 17:00
Wo
Kontakttelefon
Teilnehmer
who intend to register generics and/or biosimilars in Russia or support the
registration process by providing the essential data.
The seminar is especially interesting for:
- clinical affairs
- medical affairs
- regulatory affairs people.
Aims and objectives:
Since the introduction of Federal Law 61 in 2010 for registrations of medicinal drug products in Russia, local clinical trials have been mandatory. This has led to an increase in local bioequivalence studies.
On the other hand the number of drug registrations is decreasing. The hurdles for generic registration are very high and cost intensive.
This seminar provides you with an update on the current regulatory requirements when applying for a registration (biosimilars or generics). You will be informed of your duties regarding the dossier and application process and learn in detail how to fulfill the requirements arising through the new bioequivalence guidelines.
Topics:
- Legal background for a generic registration
- Current challenges in biosimilar registrations
- Dossier and registration process
- Local bioequivalence studies according to the new Russian guidelines
