Expert Profile

Beat Widler
Managing Partner, Widler and Schiemann AG
Dr. Beat Widler is a Ph.D. graduate from the Swiss Federal Institute of Technology in Zurich, and holds the Swiss Diploma of Pharmaceutical Medicine. He operates as an independent CQA, quality risk management, GCP and pharmacovigilance auditing expert and is managing partner at Widler & Schiemann AG in Zug Switzerland.
Over his 30-year long career in the pharma industry he built his extensive knowledge in the field of clinical development. From 1986 till 2011, Dr. Widler worked for Hoffmann-La Roche first as an international drug regulatory affairs officer, then as a senior clinical research scientist. In 1993 he then joined the international clinical quality assurance department. From 1997 to 2011, he was the global head of the department for quality, ethics and systems’ in Roche Pharma.
Dr. Widler is an active member in a variety of international GCP working parties and he regularly lectures at DIA, EFGCP, WHO, ECPM (University Basel) seminars. In the areas of quality risk management and Quality by Design he was an active member of the CTTI (Clinical Trials Transformation Initiative) and OECD working groups. He is a founding member of ACRES – the Alliance for Clinical Research Excellence and Safety, founding member of the Midata Cooperative and a member of the SAFE-Biopharma Advisory Board. He was the project leader for the development of the Association of the British Pharmaceutical Industry (ABPI) Clinical Trial Disclosure Toolkit, released in August 2013.
Trainings by Expert
ICH Addendum and its Implication on Clinical Development
Category:
Clinical Research
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Risk Management
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Audits & Inspections
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Trial Design and Management
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Clinical Trial Regulations
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Risk Management & Controls
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All FDA Regulated Functions
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Documentation and Policy Management
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Regulations & Guidances
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Regulatory Affairs
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Documentation and Data Management
Risk-Based Monitoring Beyond the RACT
Category:
Drugs and Chemicals (Pharma)
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Clinical Research
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Risk Management
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GXP Pharmaceutical
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GCP & Other Best Practices
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Trial Design and Management
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Clinical Trial Regulations
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Regulations & Guidances
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Regulatory Affairs
How to Build Effective Metrics for Vendor Oversight
Category:
Clinical Research
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GCP & Other Best Practices
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Outsourcing
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Trial Design and Management
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Clinical Trial Regulations
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Regulations & Guidances
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Regulatory Affairs







