Biopharma Excellence, a consulting group specialised in the scientific and strategic development of biopharmaceuticals from early candidates to approval, welcomes Dr. Michael Pfleiderer as a new member of our team. Dr. Pfleiderer is an internationally renowned expert in regulatory affairs and development of vaccines with almost 20 years of experience. As a former Head of the Section “Human Viral Vaccines” and later on of the Section “International Cooperation and Regulatory Services” at the Paul-Ehrlich-Institut (PEI), the German Federal Institute for Vaccines and Biomedicines, he was responsible for all issues related to vaccine licensing and regulation, for batch testing and release as well as for inspection-related aspects. His team has had a leading function as Rapporteur, Co-Rapporteur or Peer Reviewer for a significant proportion of the Marketing Authorization Applications for vaccines submitted to the European Medicines Agency (EMA).
Dr. Pfleiderer has actively developed and steered the European regulatory system in general as a member of the CHMP Biologics Working Party (BWP) and more specifically for vaccines, in his roles as Chair of the CHMP Vaccine Working Party (VWP), BWP’s influenza ad hoc working group but also as Chair and Vice Chair of EMA’s Pandemic Task Force and as a member of EMA’s Ebola Task Force.
Dr. Pfleiderer was also closely involved in numerous vaccine specific activities coordinated by the World Healthy Organization (WHO) in particular in his function as the Head of the WHO Collaborative Center for Vaccine Evaluation and Standardization that was established at PEI in August 2014.
Biopharma Excellence is happy to extend their team of biopharmaceutical experts and will broaden their scope of expertise to all scientific, regulatory and strategic aspects related to vaccines.
Biopharma Excellence is based in Munich, Germany, with experts located in other EU countries, in Switzerland, in the US, in Japan. We provide clients with unique strategic expertise related to biopharmaceuticals. As biopharmaceuticals are special our mission is to deliver unique expertise to allow efficient development and approval of new medicines.
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