Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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Drug Therapy in Rare Diseases

Seminar 1: European Pharmaceutical Regulatory Environment - Rembert Elbers

Orphan medicinal products in the EU/EEA
  • Legal basis and provisions
  • Orphan designation
  • Orphan status
  • Market exclusivity and further incentives
  • Annual report
  • Register
  • Marketing authorisation procedure
  • Strategy

Length: 97 min
plus 19% VAT
Access time 2 day(s)
Back to all presentations of seminar 1.

The Speaker:

Prof. Dr. Rembert Elbers is currently Head of BfArM Unit "Orphan Drugs and Rare Diseases."

He studied chemistry and medicine in Hannover and Munich and gains over 41 years of experience. Initially, he worked at the Institute for Physical Biochemistry, LMU Munich, investigating the intracellular compartimentation of energy metabolism. Later, he moved to the Walther Straub Institute for Pharmacology of the LMU Munich investigating molecular mechanisms for the toxicity of amino- and amidophenol derivatives. After joining the BfArM, he worked 1987 - 2000 as a head of unit in charge of scientific co-ordination of NCE drug assessment and European and International matters relating to drug regulatory affairs. From 2000 - 2012 he headed the BfArM Oncology, Haematology und Immunology unit. Since 2000 he is also the German member of the European Committee on Orphan Medicinal Products (COMP) and tasks related to this position are now his main duties at the BfArM.