PharmaFORUM Webcast Biologics

Descrizione

  • Regulatory requirements for combinations of drugs and devices 
  • Human antibodies - Case studies • Questions at the interface of CMC and non-clinics: How to contribute to successful non-clinical drug development 
  • Filing for a BLA vs MAA application with focus on the CMC requirements 
  • Advantages and disadvantages of different approval procedures (MRP/DCP/CP) 
  • and more

Programm

  • 25/04/2023, h. 14:00 CET
    Questions at the interface of CMC and non-clinics - how to contribute to successful non-clinical drug development
    Dr. Alexandra Günzl, Karyon Biopharma Consulting e.U.
    Per saperne di più
  • 17/05/2023, h. 14:00 CET
    First-in-human (FIH) clinical trial applications and INDs for ATMPs: special considerations
    Dr. Christopher Mann, ASPHALION S.L., Barcelona
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  • 15/06/2023, 14:00 CET
    Filing for a BLA vs MAA application with focus on the CMC requirements
    Dr. Christina Juli, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
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  • 19/07/2023, 14:00 CET
    Non-clinical aspects of RNA-based drug development
    Dr. Anika Schröter, Dr. Anika Schroeter e.U., Vienna, Austria
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  • 10/08/2023, 14:00 CET
    Marketing Authorisation in Brazil with a focus on CMC
    Ana Terra Dos Santos Macedo, PAREXEL International, São Paulo, Brazil
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  • 19/09/2023, 14:00 CET
    The new Clinical Trial Regulation and the Go-Live of Clinical Trial Information System (CTIS)
    Katharina Mayer, Senior Consultant, MAIN5 GmbH & Co. KGaA, Frankfurt
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  • 12/10/2023, 14:00 CET
    Advantages and disadvantages of different approval procedures (MRP/DCP/CP)
    Dr. Andreas Bonertz, Paul-Ehrlich-Institut Federal Institute for Vaccines and Biomedicines, Langen, GERMANY
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  • 9/11/2023, 14:00 CET
    Hospital exemption in the initial application and regulatory context
    Dr. Alexander Natz, LL.M., Novacos Rechtsanwälte, Düsseldorf
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  • 14/12/2023, 14:00 CET
    CMC requirements for Gene Therapy Medicinal Products: US and EU jurisdiction
    Dr. Ralf Hess, Principal Project Consultant, Entourage GmbH, Munich
    Per saperne di più


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