Management of Clinical Trials – Audits and Inspections

• Gain a comprehensive understanding of quality management systems in healthcare settings.
• Develop proficiency in conducting audits to assess compliance with regulatory standards and internal policies.
• Understand the purpose and conduct of regulatory inspections by health authorities.
• Learn strategies for preparing sites and stakeholders for regulatory inspections.
• Identify best practices for responding to observations and findings from regulatory inspections.

• Proficiency in implementing and maintaining quality management systems in healthcare environments.
• Ability to plan, execute, and document audits effectively to assess compliance with regulatory standards.
• Understanding of the objectives and procedures of regulatory inspections and their implications for healthcare organizations.
• Skill in conducting site preparations for regulatory inspections, including ensuring compliance with applicable regulations and standards.

CHF 1,800

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)

• Copy of identity document
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter

~8h-18h

• Dr Isabelle MERCIER
• Dr Isabelle SEMAC