Content CAS ETH in Regulatory Thinking

Modules

Regulatory Thinking (RT) is a methodological thinking approach. RT will be applied to the research and development efforts to ensure that the most promising research results can be translated into clinical applications. Regulatory Thinking is part of a company’s business strategy that considers the interests of the various stakeholders in medical technology, in vitro diagnostics, pharmaceuticals and biotechnological products, including future technologies.

The CAS ETH RT consists of the following modules:

Regulatory World

• Stakeholders: From patient to payors
• Regulatory Landscape
• Development process

Regulatory Thinking

• Interaction with the Regulator
• Regulations / Directives / Laws / Guidelines
• Safety / Efficacy / Performance / Transparency
• QMS

Intended Use / Indication

• Medical need assessment
• Intended Use / Indication
• Development plan
• Risk assessment

Development Process: Preclinical

• GLP
• Preclinical Safety & Efficacy Assessment
• Starting dose (first in human)

Production / GMP

• GMP
• Scaling up process
• Drug Quality

Development Process: Clinical

• GCP / Ethics
• Phase I, II, III
• Submission to ethic committee, regulator

Approval / Post Market Activities

• Market Access
• HTA / Vigilance / Pricing / Reimbursement
• Lifecycle Management

Success Factors

• Discuss own projects