SCIENTIFIC ADVISORY BOARD

Since the creation of the company, a Scientific Advisory Board challenges and guides Aseptic Technologies in its developments to ensure full compliance with the latest pharmaceutical requirements. To that end, the Aseptic Technologies’ Scientific Advisory Board gathers Doris L. Conrad, Russell E. Madsen, Dr. Klaus Haberer and Michel De Vleesschouwer.

 

Doris L. Conrad has a huge experience in quality assurance, regulatory compliance, and validation for small volume injectable products she gained when working for SmithKline Beecham Pharm and GSK Biologicals. She is currently acting as independent consultant and presides at the Science Advisory Board.

 

Russell E. Madsen had served the Parenteral Drug Association as Acting President and was Senior VP Science and Technology, responsible for the overall scientific, technical and regulatory affairs activities of the association. He holds a B.S. from St. Lawrence University and a M.S. in Chemistry from Rensselaer Polytechnic Institute. He currently is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, serves as a member of the USP Parenteral Products-Industrial Expert Committee and is also President of The Williamsburg Group, engaged in pharmaceutical consulting in the areas of cGMP compliance and auditing.

 

Klaus Haberer gained his long experience in business, in particular in microbiological quality control/quality assurance and GMP, at Hoffmann-La Roche Deutschland in Grenzach and at Hoechst AG in Frankfurt, where he as the director for microbiological quality control in the global directorate. Dr. Haberer is German expert at the European Pharmacopoeia in Strasburg, where he is also particularly engaged in the area of international harmonization of microbiological procedures. Currently he serves as a member of the PDA Scientific Advisory Board, and also as Convenor of ISO 198WG9, the working group which composes ISO 13408 series of standards on aseptic processing of medicinal products. He is managing director of Compliance, Advice and Services in Microbiology in Cologne, a company engaged in microbiological consulting and laboratory services.

 

Michel De Vleesshouwer (pharmacist, Dr pharmaceutical sciences)is professor and head of the laboratory of pharmaceutical microbiology at the Institute of Pharmacy of the Université Libre de Bruxelles. He is also head of the Biocontaminant unit of the school of Public Health of the same University. For more than 3 decades he is conducting research and teaching in Pharmaceutical microbiology and environmental microbiology as well as performing cooperative work with many industries. He is member of the Belgian Pharmacopeia and expert at the European Pharmacopoeia in Strasburg.