Parexel beefs up European GMP expert team

This move is supported by the appointment of three consultants based in Europe who all have expertise in manufacturing regulatory requirements. Clive Brading, formerly part of the quality assurance (QA) team at Sanofi Aventis, has been named director of the European consulting squad, while Dr Ralf Hess, who served as chief scientific officer for HISS Diagnostics, and Dr Siegfried Schmitt, previously a global QA director for Amersham Health, have both been appointed as principal consultants. "As biopharmaceutical companies face intensifying safety obligations, rising operational costs, and the complexities of EU regulations and ICH quality guidelines, they need help to proactively and effectively manage these hurdles,"​ said Gadi Saarony, corporate vice president and worldwide head of Parexel Consulting. "We are responding to client needs by expanding our established cadre of GMP experts located in Europe."​ The European drug regulatory body, the European Medicines Agency (EMEA) , has recently taken steps to harmonise GMP compliance processes. In particular, May saw the agency set up an online database - EudraGMP - detailing information on all manufacturing and importation certificates and authorisations issued within the EU medicines network in a bid to ease the strain of exchanging vast amounts of information on compliance with GMP within the European Economic Area. Meanwhile, the booming biologics market has increased the intricacy in manufacturing regulations and the EMEA has had to alter certain parts of the GMP rulebook to adapt to these complex products. ​ An annex of the GMP Guide has recently been revised as a consequence of the introduction of GMP for active substances used as starting materials, in other words biotech drugs. According to the EMEA, further revision was necessary due to an increase of breadth of biological products. In addition, with the agreement on the new regulation on advanced therapies, the Commission has been asked to draw up specific GMP guidelines for advanced therapy medicinal products, including gene therapy, somatic cell therapy medicinal products and tissue engineered products as defined in the regulation.