Ralf Hess

Company: PAREXEL
Ralf

Dr. Ralf Hess holds a PhD degree in virology and immunology together with a Masters degree in biology (genetics, microbiology, cell biology and organic chemistry) from the University of Freiburg, Department of Virology, Germany and subsequently held an academic position in the Department of Virology between 1987 and 1996 during which time he focused on medical virology, diagnostics and epidemiology. Ralf has extensive experience in academia, industry and the regulatory environment and is a Principal Consultant at PAREXEL and is affiliated with ASM (American Society for Microbiology) since 1996, ESCV (European Society for Clinical Virology) since 2004, GfV (Gesellschaft für Virologie = Society for Virology, DE, AUT, CH) since 1990, DGHM (Deutsche Gesellschaft für Mikrobiologie und Hygiene, German Society For Microbiology and Hygiene) since 1999, BioValley Deutschland e.V. (Freiburg, Germany) since 1996, a member of European QP (Qualified Person) Association since 2007, a member of European Society of Virology (new organization (04/09) since June 2009, an ECA (European Compliance Academy) and PDA (Parenteral Drug Association) member. Prior to his position at PAREXEL, Ralf was the Chief Scientific Officer at HISS Diagnostics (1996 to 2007), an in-vitro diagnostic medical device manufacturer where he was responsible for R&D, manufacturing as well as being Head of Regulatory Affairs. Ralf has extensive knowledge of medical device regulations (ISO, certification and accreditation), GLP, GCLP and GMP and was registered as a Qualified Person with Swiss Medic (2007-2012). In the time that Ralf has been at PAREXEL (more than 7 years) his expertise in virus safety and manufacturing has meant he has been actively involved in identifying and resolving competitive GMP compliance issues, advising on biological assay selection and validation as well as assessing biosafety concerns for various biotechnology products including biosimilars, and vaccines. Ralf is also a recognized expert in immunogenicity and has extensive knowledge of biological assay platforms and their application to immunogenicity testing and assessments. Ralf understands EU GMP and regulatory affairs legislation for drug and devices and provides strategic compliance services for drug, device and drug-device combination product manufacturer. He recently became an APIC certified Auditor (eff. from June 5, 2014) for ICHQ7 Biologics.