Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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Format and Content of the Marketing Authorisation Application (MAA) Dossier: The Common Technical Dossier (CTD) and eCTD

Seminar 1: European Pharmaceutical Regulatory Environment - Michael Schaub

  • General aspects of the harmonised CTD
  • eCTD

Length: 42 min
plus 19% VAT
Access time 2 day(s)
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The Speaker:

Michael holds a degree in biology from the University of Konstanz, Germany. He started his scientific career participating in several research projects at the Oregon State University and the Florida Atlantic University. In 2006, he returned to Europe and continued his work as a research scientist at the Centre for Genomic Regulation in Barcelona.

He began his career as a regulatory affairs consultant when he joined ASPHALION, S.L. in 2007. Nowadays, his responsibilities include the strategy and management of international drug registration procedures, the preparation and evaluation of the respective dossiers, as well as the conduct of scientific advice procedures and pre-submission meetings with international regulatory authorities. He acquired specific knowledge in several projects for innovative products, such as Biologicals and Advanced Therapy Medicinal Products. Other areas of his expertise include the strategic preparation of paediatric investigation plans as well as the implementation of electronic submission standards.

In 2013, Michael moved to Munich, thus returning to his home country Germany, where he established ASPHALION’s first branch office.

More information on the seminar.