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

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