BOSTON, Sept. 18 PAREXEL Consulting, a businessunit of PAREXEL International (Nasdaq: PRXL) and a leading global lifesciences consultancy serving the bio/pharmaceutical and medical deviceindustries, announced today that it is strengthening its Good ManufacturingPractice (GMP) capabilities in Europe to help its global client base addresscomplexities of European Union (EU) directives in areas such as manufacturingregulations, quality, and safety.
This initiative includes the addition of three senior consultants to thePAREXEL Consulting team based in Europe. Clive Brading, formerly in a seniorCorporate Quality Assurance role at Sanofi-Aventis, has been appointed to theposition of Director to lead the PAREXEL Consulting European team of expertsfocused on strategic compliance and operational process excellence. Dr. RalfHess, who served as Chief Scientific Officer for HISS Diagnostics GmbH, andDr. Siegfried Schmitt, previously a global Quality Assurance Director forAmersham Health (now GE Healthcare), have both been appointed to the positionof Principal Consultant.
"As biopharmaceutical companies face intensifying safety obligations,rising operational costs, and the complexities of EU regulations and ICHquality guidelines, they need help to proactively and effectively manage thesehurdles," said Gadi Saarony, Corporate Vice President and Worldwide Head ofPAREXEL Consulting. "We are responding to client needs by expanding ourestablished cadre of GMP experts located in Europe, represented by theappointments of Mr. Brading, Dr. Hess, and Dr. Schmitt."
"Clients rely on our team of specialists for traditional GxP requirements,but also need help with more contemporary challenges, such as maximizingreturn on investment during post-merger integration, developing robustpharmacovigilance strategies, reducing the risk of counterfeit drugs,implementing ICH quality guidelines, and adopting complex processtechnologies," said Clive Brading, Director, PAREXEL Consulting.
Prior to his senior role in Corporate Quality Assurance for Sanofi-Aventis, Mr. Clive Brading held quality and manufacturing positions at avariety of pharmaceutical organizations, both at the corporate andmanufacturing site levels. His expertise includes manufacturing and supplyrequirements in global markets, such as Europe, the U.S. and Japan, andexperience with all major pharmaceutical dosage forms. Mr. Brading has servedas Chairman of the European Federation of Pharmaceutical IndustriesAssociations (EFPIA) Manufacturing and GMP ad-hoc groups.
As Chief Scientific Officer for HISS Diagnostics GmbH, Dr. Ralf Hess wasresponsible for research and development of in-vitro diagnostics andregulatory affairs. Previously, he held a post-doctoral research position inthe Department of Virology at the University of Freiburg, Germany, where hereceived a Ph.D. and Masters in Biology. Dr. Hess has been certified as aQuality Control inspector and received certification under German MedicalProducts Law (MPG). He was recently recognized as Deputy Qualified Person bySwissmedic, the central Swiss supervisory authority for therapeutic products.He is an active member of various societies, including the American Societyfor Microbiology and the European Society for Clinical Virology. Dr. Hessoften presents and publishes on topics related to medical microbiology.
Prior to his position as global Quality Assurance Director in InformationManagement for Amersham Health, Dr. Siegfried Schmitt was Senior LeadConsultant with ABB Eutech and previously worked as a consultant andvalidation manager for Raytheon E&C and senior production chemist for F.Hoffmann-La Roche. Dr. Schmitt is a Member of the Royal Society of Chemistryand is a Chartered Chemist and Chartered Scientist. He is also a member ofseveral industry organizations, and was recently elected U.K. ChapterPresident of the Parenteral Drug Association