Dr. Hannelore Willkommen works as Consultant for Regulatory Affairs and Biological Safety of biopharmaceuticals. She is active in international organisations like PDA (Parenteral Drug Association) and she leads at present PDA’s Biotech Interest Group in Europe.
Hannelore Willkommen worked for more than 25 years at the German regulatory agency, the Paul-Ehrlich Institute. In this capacity, she was responsible for the marketing authorisation and supervision of biological medicinal products and, as her special field, for the viral and TSE safety assessment of biopharmaceuticals in national and European license procedures. Dr. Willkommen played a leading role in drafting national and European guidelines on viral and TSE safety of biotech and blood products.