Dr Votava lectures at a Conference about Biological Treatment and Biosimilars
Jun 9, 2015
On Thursday June 11th, PharmInvent Chief Medical Officer (CMO) Dr Martin Votava, along with five other experts, will be lecturing at a conference focusing on the topics of biological treatment and biosimilars.
During his presentation Requirements for a successful registration of biological products and biosimilars, Dr. Votava will cover the following topics:
- Registration process of biological products and biosimilars
- The main differences between the registration of biological products and biosimilars
- EMA´s requirements for proving efficacy and safety
- The content and extent of the documentation presented
- Preclinical trials and clinical evaluation
- The proof of bioequivalence with the reference product
- Portability of data from abroad
- SmPC - therapeutic indications, pharmacological data
- Biological drugs and biosimilars from the perspective of pharmacovigilance
For the programme (in Czech) please visit http://www.konferenceseminare.cz/biologicka-lecba-a-biosimilars.
If you wish to participate in the conference, please contact us.