Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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Dr. Gabriele Dallmann, Study Director
Event Manager

Zsuzsanna Nandori, Event Manager
EUCRAF
Jutatstraße 26
80636 München

Tel.:+49 (0) 89 44 23 5997
E-mail:info@eucraf.eu

Blood products

Seminar 3: Registration of blood products, vaccines and ATMPs - Gabriele Dallmann


Introduction

The product class of blood products

 

  • Overview on currently approved products
  • Manufacturing methods and quality control approach
  • Requirements for the selection of the starting material
  • Pre-clinical and clinical data requirements
    • Certification scheme on Plasma Master File (PMF)

 

Plasma-derived products as a component of a medical device

 
Length: 173 min

412.00
plus 19% VAT
Access time 2 day(s)
Back to all presentations of seminar 3.

The Speaker:
 

Dr. Gabriele Schäffner-Dallmann is an internationally renowned biopharmaceutical expert with more than 25 years of experience in drug development and regulatory affairs of biopharmaceuticals. At the Paul-Ehrlich-Institut where she was Head of the Section "Mono- and polyclonal antibodies" she has been involved in the European process of authorisation of biopharmaceuticals and represented the PEI in committees and working parties of the EMA in London. Stimulated by discussions on the lack of an adequate training platform providing young professionals with the distinctive knowledge on biopharmaceutical-related regulatory affairs she initiated in 2006 an intensive dialogue with distinguished experts from authorities, universities and companies to develop EUCRAF. Dr. Dallmann works as a biopharmaceutical consultant and is involved in development, strategic and market access projects, regulatory submissions, scientific advice and due diligence procedures.

She is biologist with a PhD in immunology from Berlin University and visiting lecturer on biopharmaceuticals at Freiburg University.


More information on the seminar.