Peter Schiemann, PhD
Managing Partner and Co-Founder
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11 years industry experience with Roche in Switzerland and the US (Trade Packaging, In-Process Control, Clinical Supplies, Clinical Audit Planning, Quality Risk Management)
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4 years with PricewaterhouseCoopers (PwC) in Switzerland and the US (R&D Strategy consulting)
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3 years academic research in Germany
Specialties
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Quality Risk Management and Quality by Design
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Chinese Drug Development Regulations
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Risk-based Monitoring
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Process analysis and re-engineering
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Clinical Trial Management
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SOP Systems and Process flow
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Strategic R&D Advice
Experience
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Lead, created and implemented a novel Quality Risk Management approach in Clinical Trials and Drug Safety at major pharmaceutical company including strategy, concept, methodology, process and organizational design and implementation
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Initiated major Clinical Trials Phase IIIb/IV re-engineering project at a major pharmaceutical company including design and implementation while serving on the steering committee and as major contributor in multiple work streams
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Implemented system for clinical trials and quality management, involving regulatory, quality, clinical, manufacturing and medical departments for biotech start-up
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Lead a Risk-based Monitoring project a mid size Pharmaceutical Company
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Lead the team for the analysis of an R&D strategy and organizational set up of a small US Biotech company including development of a restructuring plan and recommendations for a strategy shift
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Development and implemented Clinical Quality Management Systems at various clients (small and mid size), including SOPs in Europe and China
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Trainer on standard course on Risk-based Monitoring and targeted Source Data Verification
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Re-engineered a system for quality management, clinical trials, manufacturing and marketing for a medical device company
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Performed numerous key organizational analyses including R&D, Manufacturing and IT processes
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Close contact with regulators at FDA, EMA, NMPA (former CFDA), BfArM, MHRA, ANSM and others
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DIA QRM SIAC Chair and ACRES IT systems workstream co-chair