Dieter Wachtmann is currently working as Senior Manager Regulatory Intelligence for PAREXEL International in cooperation with other SMEs to identify potential and actual changes in the Regulatory environment that effect the way the company manages clinical trials and communicates regulatory changes to allow in-time alignment of PAREXEL’s regulatory strategy, framework and procedures as applicable. Before taking over this responsibility he worked as Validation Manager in PAREXEL’s Technology Quality Management department for 4.5 years on computerized system validation with some focus on EDC & Clinical Logistics systems. He ensured system compliance with (inter)national regulations & corporate quality standards, participated to vendor qualification/compliance activities, was responsible for the regulatory compliance of the corporate system validation framework and represented the systems in client audits. In addition he managed PAREXEL’s RFI responses in the area of Validation and IT Security and developed a TQM Knowledge Base summarizing all relevant info dealing with system validation and the related GCP and GMP requirements. Before joining PAREXEL he worked 10 years for Datatrak International (a US based EDC vendor) in different management positions with responsibility for the overall corporate quality system, system testing & validation, test outsourcing, SDLC/CTLC related QA aspects, all kinds of audits & CAPA, QA-consulting, business intelligence, and QA team-, system-, & process integration after the acquisition of another EDC company. Finally he was responsible for the European Datatrak facilities in a Managing Director position. Dieter is member of the International Society for Pharmaceutical Engineering (ISPE) and the German Society for Good Research Practice (DGGF). Within the ISPE he is an active member of the ISPE R&D and Clinical Systems Special Interest Group (SIG). He holds a PhD degree in Cell Biology & Diploma in Zoology and has worked as scientific assistant/assistant head of a scientific working group and as manager of a scientific library for 10 years before starting to work for the pharmaceutical industry.