Dr. Dieter Wachtmann

QMSO leadership team member Coordinator for corporate ICH GCP E6R2 implementation Oversight/cross-functional analysis of new (inter)national regulations Represented regulatory area in client audits Regulatory newsletter (audience > 600) Search engine for regulatory/quality info (> 30.000 news items) > 50 Special Topic Pages (Knowledge Mgmt) with regulatory & industry info Responsibility for info area about relevant Covid 19 aspects Optimized QMS RFI/RFP standard responses

Evaluated regulatory trends and emerging regulations Implemented a Governing Body of SMEs for critical regulatory changes Implemented a SharePoint framework hosting all regulatory and quality related information (> 450 pages) Worked together with other internal subject matter experts for relevant cross functional impact evaluation and communicated relevant analysis results with the process owners

Internal consulting for comp. systems validation teams TQM departments regulatory compliance (EMA, FDA, MHRA & ICH) Validation projects (EDC/Logistics) & representation in client audits Leadership to process optimization & technical trainings TQM Lead for international client interacting with client’s validation team RFI standard responses library covering TQM & IT Security & responses for clients RFI requests Biweekly newsletter: validation, quality aspects & regulatory trends

Managed the DATATRAK Deutschland GmbH business operations Supported Exec Mgmt in developing international strategies and processes Represented GmbH at executive meetings Represented DATATRAK in client audits performed in Europe Industry/competitor intelligence for the Exec Mgmt Confidant and point person for all departments and employees working at the German office for the communication and cooperation between all 3 DATATRAK facilities

Head of corporate QMS group/substitute of International QA Director Corporate QMS responsibility Mentor for QA groups in all 3 offices Compliance with (inter)national regs & guidance CAPA responsibility Client audits Internal audits Qualification audits for DATATRAK suppliers Datatrak consulting group member providing validation & general QA advise for clients undergoing EDC tech transfer

Compliance with (inter)national regulatory requirements Customer/internal/supplier audits EDC release/maintenance mgmt Managed QA test resources Optimized test methodology/concepts/scripts Assessed corporate QMS, validation standards & other procedures for EDC supplier acquisition QMS integration activities after EDC vendor acquisition (QMS harmonization) QMS & validation assessment of outsourcing partner (Poona/India) Trained/led outsourced team of QA testers (Poona/India)

Release/maintenance validation ccordination for 4 major EDC software versions and internal tools Responsibility for system validation in various client audits Responsible for maintenance/optimization of the EDC test process Head of the EDC testing group Coordinator of the retrospective validation of DATATRAK EDC 2.2) Major participation in SDLC development Coordination of the corporate Y2K Compliance program

Functional & user acceptance tests for DataTRAK EDC, Test Case updates/development

Assistant head/head of a scientific working group, Supervision of scientific/technical staff, practical courses/seminars, Outline of research projects, Lectures & scientific publications, head of scientific library, Scientific employees’ representative

Database design, programming, administration and modeling, SQL, HTML programming, Web page edition,

Cytoskeleton dynamics in epithelial cells, immunocytochemistry, cellular transports, motor proteins,