RUSSIA: Registration of Generics and Biosimilars - Local bioequivalence and tox studies required!
- Legal background for a generic registration
- Current challenges in biosimilar registrations
- Dossier and registration process
- Local bioequivalence studies according to the new Russian guidelines
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.
Termin
| Datum: | 30.01.2015 |
| Ort: | Leonardo Royal Hotel Berlin Alexanderplatz Otto-Braun-Straße 90 -10249 Berlin |
| Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar addresses the needs of
co-workers of the pharmaceutical industry
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.
Kontaktinformationen
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