Beate R. Schmidt, MSc, MDRA, RAC
- Accomplished regulatory professional with more than 18 years of in-depth experience in the development and licensing of innovative and follow-on medicinal products.
- Biologist by training (MSc from Heidelberg University, Germany). Professional education also includes a postgraduate Master’s degree in Drug Regulatory Affairs from the University of Bonn (Germany) as well as the Regulatory Affairs Certification (RAC) for the US and the EU from the Regulatory Affairs Professionals Society (RAPS).
- Post-graduate Master’s degree in Health Economics, Policy and Management from the London School of Economics (LSE) as well as Market Access Manager (EBS) from the European Business School (Oestrich-Winkel, Germany).
- Various executive positions in the global biotechnology and pharmaceutical industry including Associate Director, Regulatory Affairs at Aspreva Pharmaceuticals Corp. (Victoria, BC, Canada) and Director, Regulatory Affairs at Micromet AG (Munich, Germany).
- Scientific Administrator in the Safety and Efficacy of Medicines sector of the European Medicines Agency (EMA) in London from 2009 to 2012, with responsibility, as a Product Team Leader, for the coordination of diverse regulatory procedures – from initial marketing authorisation applications to life-cycle management – for a broad range of leading-edge and follow-on products.
- Therapeutic area experience includes oncology/haematology, rheumatology and autoimmune disorders, immunological and transplant indications as well as blood products.
- Extensive practical work experience in Europe and North America (Canada, US).
- Internship at the German Federal Joint Committee (Gemeinsamer Bundesausschuß, G-BA) in Berlin in 2012.
- Freelance regulatory consultant to the pharmaceutical and biotechnology industry as of 2012.